# Official Journal L 126/2022

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 126 |
| | |
| English edition | Legislation | Volume 6529 April 2022 |

ISSN 1977-0677

Official Journal

of the European Union

L 126

English edition

Legislation

Volume 6529 April 2022

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | INTERNATIONAL AGREEMENTS |
| | * | Information concerning the entry into force of the Protocol to amend the Air Transport Agreement between the United States of America and the European Community and its Member States | 1 |
| | | REGULATIONS |
| | * | Council Regulation (EU) 2022/681 of 28 April 2022 amending Regulation (EU) 2022/109 fixing for 2022 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in Union waters and for Union fishing vessels in certain non-Union waters | 2 |
| | * | Commission Delegated Regulation (EU) 2022/682 of 25 February 2022 amending Regulation (EU) 2018/196 of the European Parliament and of the Council on additional customs duties on imports of certain products originating in the United States of America | 4 |
| | * | Commission Implementing Regulation (EU) 2022/683 of 27 April 2022 amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin | 7 |
| | * | Commission Implementing Regulation (EU) 2022/684 of 28 April 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food galacto-oligosaccharide (
  1
  ) | 10 |
| | * | Commission Implementing Regulation (EU) 2022/685 of 28 April 2022 amending Regulation (EC) No 333/2007 as regards the sampling requirements for fish and terrestrial animals (
  1
  ) | 14 |
| | * | Commission Implementing Regulation (EU) 2022/686 of 28 April 2022 amending Implementing Regulations (EU) 2015/1295 and (EU) No 540/2011 as regards the conditions of approval of the active substance sulfoxaflor (
  1
  ) | 18 |
| | | DECISIONS |
| | * | Decision (EU) 2022/687 of the Representatives of the Governments of the Member States of 27 April 2022 appointing Judges to the General Court | 23 |
| | | GUIDELINES |
| | * | Guideline (EU) 2022/688 of the European Central Bank of 22 April 2022 amending Guideline 2013/47/EU on a Trans-European Automated Real-time Gross settlement Express Transfer system (TARGET2) (ECB/2012/27) (ECB/2022/20) | 25 |

Contents

II   Non-legislative acts

page

INTERNATIONAL AGREEMENTS

*

Information concerning the entry into force of the Protocol to amend the Air Transport Agreement between the United States of America and the European Community and its Member States

1

REGULATIONS

*

Council Regulation (EU) 2022/681 of 28 April 2022 amending Regulation (EU) 2022/109 fixing for 2022 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in Union waters and for Union fishing vessels in certain non-Union waters

2

*

Commission Delegated Regulation (EU) 2022/682 of 25 February 2022 amending Regulation (EU) 2018/196 of the European Parliament and of the Council on additional customs duties on imports of certain products originating in the United States of America

4

*

Commission Implementing Regulation (EU) 2022/683 of 27 April 2022 amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin

7

*

Commission Implementing Regulation (EU) 2022/684 of 28 April 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food galacto-oligosaccharide (
  1
  )

1

10

*

Commission Implementing Regulation (EU) 2022/685 of 28 April 2022 amending Regulation (EC) No 333/2007 as regards the sampling requirements for fish and terrestrial animals (
  1
  )

1

14

*

Commission Implementing Regulation (EU) 2022/686 of 28 April 2022 amending Implementing Regulations (EU) 2015/1295 and (EU) No 540/2011 as regards the conditions of approval of the active substance sulfoxaflor (
  1
  )

1

18

DECISIONS

*

Decision (EU) 2022/687 of the Representatives of the Governments of the Member States of 27 April 2022 appointing Judges to the General Court

23

GUIDELINES

*

Guideline (EU) 2022/688 of the European Central Bank of 22 April 2022 amending Guideline 2013/47/EU on a Trans-European Automated Real-time Gross settlement Express Transfer system (TARGET2) (ECB/2012/27) (ECB/2022/20)

(ECB/2022/20)

25

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

INTERNATIONAL AGREEMENTS

| 29.4.2022 | EN | Official Journal of the European Union | L 126/1 |
| --- | --- | --- | --- |

29.4.2022

EN

Official Journal of the European Union

L 126/1

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Information concerning the entry into force of the Protocol to amend the Air Transport Agreement between the United States of America and the European Community and its Member States

The Protocol to amend the Air Transport Agreement between the United States of America and the European Community and its Member States, signed in Luxembourg on 24 June 2010, will enter into force on 5 May 2022, in accordance with Article 10(2) of the Protocol, as the last notification was deposited on 5 April 2022.

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REGULATIONS

| 29.4.2022 | EN | Official Journal of the European Union | L 126/2 |
| --- | --- | --- | --- |

29.4.2022

EN

Official Journal of the European Union

L 126/2

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COUNCIL REGULATION (EU) 2022/681

of 28 April 2022

amending Regulation (EU) 2022/109 fixing for 2022 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in Union waters and for Union fishing vessels in certain non-Union waters

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) 2022/109 (1) fixed for 2022 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in Union waters and for Union fishing vessels in certain non-Union waters. |
| --- | --- |

(1)

Council Regulation (EU) 2022/109 (1) fixed for 2022 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in Union waters and for Union fishing vessels in certain non-Union waters.

| (2) | Regulation (EU) 2022/109 established for the first quarter of 2022 a provisional Union quota of 4 500 tonnes for Union vessels fishing for cod (Gadus morhua) in Spitzbergen (Svalbard) waters and international waters of International Council for the Exploration of the Sea (ICES) subarea 1 and division 2b. Council Regulation (EU) 2022/515 (2) extended the period of application of that Union quota to 30 April 2022. |
| --- | --- |

(2)

Regulation (EU) 2022/109 established for the first quarter of 2022 a provisional Union quota of 4 500 tonnes for Union vessels fishing for cod (Gadus morhua) in Spitzbergen (Svalbard) waters and international waters of International Council for the Exploration of the Sea (ICES) subarea 1 and division 2b. Council Regulation (EU) 2022/515 (2) extended the period of application of that Union quota to 30 April 2022.

| (3) | As formal discussions with Norway on a political understanding in relation to the fisheries in ICES subareas 1 and 2 have been concluded, it is appropriate that the Council set the Union quota for cod in Svalbard waters and in the international waters of ICES subarea 1 and division 2b for 2022 accordingly, in order to replace the provisional Union quota that expires at the end of April 2022. |
| --- | --- |

(3)

As formal discussions with Norway on a political understanding in relation to the fisheries in ICES subareas 1 and 2 have been concluded, it is appropriate that the Council set the Union quota for cod in Svalbard waters and in the international waters of ICES subarea 1 and division 2b for 2022 accordingly, in order to replace the provisional Union quota that expires at the end of April 2022.

| (4) | Any quotas should be allocated to the Member States in accordance with Council Decision 87/277/EEC (3) and Poland’s share of the Union quota, and subject to the adaptations necessary due to the withdrawal of the United Kingdom from the Union. |
| --- | --- |

(4)

Any quotas should be allocated to the Member States in accordance with Council Decision 87/277/EEC (3) and Poland’s share of the Union quota, and subject to the adaptations necessary due to the withdrawal of the United Kingdom from the Union.

| (5) | Annex IB to Regulation (EU) 2022/109 should therefore be amended accordingly. |
| --- | --- |

(5)

Annex IB to Regulation (EU) 2022/109 should therefore be amended accordingly.

| (6) | The catch limits provided for in Regulation (EU) 2022/109 apply from 1 January 2022. The provisions introduced by this Regulation concerning catch limits should therefore also apply from that date. Such retroactive application does not affect the principles of legal certainty and the protection of legitimate expectations, as the fishing opportunities concerned are increased. For reasons of urgency, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, |
| --- | --- |

(6)

The catch limits provided for in Regulation (EU) 2022/109 apply from 1 January 2022. The provisions introduced by this Regulation concerning catch limits should therefore also apply from that date. Such retroactive application does not affect the principles of legal certainty and the protection of legitimate expectations, as the fishing opportunities concerned are increased. For reasons of urgency, 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) 2022/109

In Annex IB to Regulation (EU) 2022/109, the fourth table is replaced by the following:

| ‘Species: | Cod

  Gadus morhua | Zone: | 1 and 2b
  (COD/1/2B.) |
| --- | --- | --- | --- |
| Germany | 4 028 | (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 | 9 688 | (1)(2) |
| France | 1 775 | (1)(2) |
| Poland | 1 829 | (1)(2) |
| Portugal | 2 019 | (1)(2) |
| Other Member States | 297 | (1)(2)(3) |
| Union | 19 636 | (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).’ |

‘Species:

Cod

Gadus morhua

Zone:

1 and 2b

(COD/1/2B.)

Germany

4 028

(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

9 688

(1)(2)

France

1 775

(1)(2)

Poland

1 829

(1)(2)

Portugal

2 019

(1)(2)

Other Member States

297

(1)(2)(3)

Union

19 636

(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).’

Article 2

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 2022.

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

Done at Brussels, 28 April 2022.

For the Council

The President

J.-Y. LE DRIAN

---

(1)  Council Regulation (EU) 2022/109 of 27 January 2022 fixing for 2022 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in Union waters and for Union fishing vessels in certain non-Union waters (OJ L 21, 31.1.2022, p. 1).

1

(2)  Council Regulation (EU) 2022/515 of 31 March 2022 amending Regulation (EU) 2022/109 fixing for 2022 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in Union waters and for Union fishing vessels in certain non-Union waters (OJ L 104, 1.4.2022, p. 1).

2

(3)  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).

3

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| 29.4.2022 | EN | Official Journal of the European Union | L 126/4 |
| --- | --- | --- | --- |

29.4.2022

EN

Official Journal of the European Union

L 126/4

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COMMISSION DELEGATED REGULATION (EU) 2022/682

of 25 February 2022

amending Regulation (EU) 2018/196 of the European Parliament and of the Council on additional customs duties on imports of certain products originating in the United States of America

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2018/196 of the European Parliament and of the Council of 7 February 2018 on additional customs duties on imports of certain products originating in the United States of America (1), and in particular Article 3(3) thereof,

Whereas:

| (1) | As a result of the United States’ failure to bring the Continued Dumping and Subsidy Offset Act (‘CDSOA’) in compliance with its obligations under the World Trade Organization (‘WTO’) agreements, pursuant to Regulation (EU) 2018/196 a 4,3 % ad valorem additional customs duty was imposed on imports of certain products originating in the United States. In conformity with the WTO authorisation to suspend the application of concessions to the United States, the Commission is to adjust the level of suspension annually to the level of nullification or impairment caused by the CDSOA to the Union at that time. In 2021, the level of suspension was adjusted to 0,1 % ad valorem additional customs duty and Regulation (EU) 2018/196 was amended accordingly (2). |
| --- | --- |

(1)

As a result of the United States’ failure to bring the Continued Dumping and Subsidy Offset Act (‘CDSOA’) in compliance with its obligations under the World Trade Organization (‘WTO’) agreements, pursuant to Regulation (EU) 2018/196 a 4,3 % ad valorem additional customs duty was imposed on imports of certain products originating in the United States. In conformity with the WTO authorisation to suspend the application of concessions to the United States, the Commission is to adjust the level of suspension annually to the level of nullification or impairment caused by the CDSOA to the Union at that time. In 2021, the level of suspension was adjusted to 0,1 % ad valorem additional customs duty and Regulation (EU) 2018/196 was amended accordingly (2).

| (2) | The CDSOA disbursements for the most recent year for which data are available relate to the distribution of anti-dumping and countervailing duties collected during the Fiscal Year 2020 (1 October 2020 – 30 September 2021). On the basis of the data published by the United States’ Customs and Border Protection, the level of nullification or impairment caused to the Union is calculated at USD 3 095,94. |
| --- | --- |

(2)

The CDSOA disbursements for the most recent year for which data are available relate to the distribution of anti-dumping and countervailing duties collected during the Fiscal Year 2020 (1 October 2020 – 30 September 2021). On the basis of the data published by the United States’ Customs and Border Protection, the level of nullification or impairment caused to the Union is calculated at USD 3 095,94.

| (3) | The level of nullification or impairment and consequently of suspension has decreased. However, the level of suspension cannot be adjusted to the level of nullification or impairment by adding or removing products from the list in Annex I to Regulation (EU) 2018/196. As a consequence, in accordance with Article 3(1)(e) of that Regulation, the Commission should keep the list of products in Annex I unchanged and amend the rate of the additional duty in order to adjust the level of suspension to the level of nullification or impairment. The four products listed in Annex I should therefore be maintained on the list and the rate of additional import duty should be amended and set at 0,001 %. |
| --- | --- |

(3)

The level of nullification or impairment and consequently of suspension has decreased. However, the level of suspension cannot be adjusted to the level of nullification or impairment by adding or removing products from the list in Annex I to Regulation (EU) 2018/196. As a consequence, in accordance with Article 3(1)(e) of that Regulation, the Commission should keep the list of products in Annex I unchanged and amend the rate of the additional duty in order to adjust the level of suspension to the level of nullification or impairment. The four products listed in Annex I should therefore be maintained on the list and the rate of additional import duty should be amended and set at 0,001 %.

| (4) | The effect of a 0,001 % ad valorem additional import duty on imports from the United States of the products in Annex I represents, over one year, a value of trade that does not exceed USD 3 095,94. |
| --- | --- |

(4)

The effect of a 0,001 % ad valorem additional import duty on imports from the United States of the products in Annex I represents, over one year, a value of trade that does not exceed USD 3 095,94.

| (5) | To make sure that there are no delays in the application of the amended rate of additional import duty, this Regulation should enter into force on the day of its publication. |
| --- | --- |

(5)

To make sure that there are no delays in the application of the amended rate of additional import duty, this Regulation should enter into force on the day of its publication.

| (6) | Regulation (EU) 2018/196 should therefore be amended accordingly, |
| --- | --- |

(6)

Regulation (EU) 2018/196 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Article 2 of Regulation (EU) 2018/196 is replaced by the following:

‘Article 2

An ad valorem duty of 0,001 % additional to the customs duty applicable under Regulation (EU) No 952/2013 of the European Parliament and of the Council (*1) shall be imposed on the products originating in the United States listed in Annex I to this Regulation.

Article 2

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 May 2022.

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

Done at Brussels, 25 February 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 44, 16.2.2018, p. 1.

1

(2)  Commission Delegated Regulation (EU) 2021/704 of 26 February 2021 amending Regulation (EU) 2018/196 of the European Parliament and of the Council on additional customs duties on imports of certain products originating in the United States of America (OJ L 146, 29.4.2021, p. 70).

2

---

ANNEX

‘ANNEX I

The products on which additional import duties are to apply are identified by their eight-digit CN codes. The description of products classified under these codes can be found in Annex I to Council Regulation (EEC) No 2658/87 (1).

| 0710 40 00 | |
| --- | --- |
| Ex90031900 | ‘frames and mountings of base metal’ |
| 8705 10 00 | |
| 6204 62 31 | |

0710 40 00

Ex90031900

‘frames and mountings of base metal’

8705 10 00

6204 62 31

---

(1)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

1

---

| 29.4.2022 | EN | Official Journal of the European Union | L 126/7 |
| --- | --- | --- | --- |

29.4.2022

EN

Official Journal of the European Union

L 126/7

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/683

of 27 April 2022

amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 183(b) thereof,

Having regard to Regulation (EU) No 510/2014 of the European Parliament and of the Council of 16 April 2014 laying down the trade arrangements applicable to certain goods resulting from the processing of agricultural products and repealing Council Regulations (EC) No 1216/2009 and (EC) No 614/2009 (2), and in particular Article 5(6)(a) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 1484/95 (3) lays down detailed rules for implementing the system of additional import duties and fixes representative prices in the poultrymeat and egg sectors and for egg albumin. |
| --- | --- |

(1)

Commission Regulation (EC) No 1484/95 (3) lays down detailed rules for implementing the system of additional import duties and fixes representative prices in the poultrymeat and egg sectors and for egg albumin.

| (2) | Regular monitoring of the data used to determine representative prices for poultrymeat and egg products and for egg albumin shows that the representative import prices for certain products should be amended to take account of variations in price according to origin. |
| --- | --- |

(2)

Regular monitoring of the data used to determine representative prices for poultrymeat and egg products and for egg albumin shows that the representative import prices for certain products should be amended to take account of variations in price according to origin.

| (3) | Regulation (EC) No 1484/95 should therefore be amended accordingly. |
| --- | --- |

(3)

Regulation (EC) No 1484/95 should therefore be amended accordingly.

| (4) | Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication, |
| --- | --- |

(4)

Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EC) No 1484/95 is replaced by the text set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day 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, 27 April 2022.

For the Commission,

On behalf of the President,

Wolfgang BURTSCHER

Director-General

Directorate-General for Agriculture and Rural Development

---

(1)  
  OJ L 347, 20.12.2013, p. 671.

1

(2)  
  OJ L 150, 20.5.2014, p. 1.

2

(3)  Commission Regulation (EC) No 1484/95 of 28 June 1995 laying down detailed rules for implementing the system of additional import duties and fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and repealing Regulation No 163/67/EEC (OJ L 145, 29.6.1995, p. 47).

3

---

ANNEX

‘ANNEX I

| CN code | Description of goods | Representative price
  (EUR/100 kg) | Security under Article 3
  (EUR/100 kg) | Origin (1) |
| --- | --- | --- | --- | --- |
| 0207 14 10 | Fowls of the species Gallus domesticus, boneless cuts, frozen | 227,6 | 22 | BR |

CN code

Description of goods

Representative price

(EUR/100 kg)

Security under Article 3

(EUR/100 kg)

Origin (1)

0207 14 10

Fowls of the species Gallus domesticus, boneless cuts, frozen

227,6

22

BR

---

(1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7).’

1

---

| 29.4.2022 | EN | Official Journal of the European Union | L 126/10 |
| --- | --- | --- | --- |

29.4.2022

EN

Official Journal of the European Union

L 126/10

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/684

of 28 April 2022

amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food galacto-oligosaccharide

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,

Whereas:

| (1) | Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union. |
| --- | --- |

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

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

(2)

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

| (3) | The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes galacto-oligosaccharide as an authorised novel food. |
| --- | --- |

(3)

The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes galacto-oligosaccharide as an authorised novel food.

| (4) | Pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3), galacto-oligosaccharide has been authorised to be placed on the market as a novel food to be used in a number of foods, including infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (4). |
| --- | --- |

(4)

Pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3), galacto-oligosaccharide has been authorised to be placed on the market as a novel food to be used in a number of foods, including infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (4).

| (5) | Commission Implementing Regulation (EU) 2021/900 (5) authorised a change of the conditions of use of the novel food galacto-oligosaccharide. In particular, the use level of the novel food galacto-oligosaccharide in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (6) was increased from 0,333 kg galacto-oligosaccharide/kg of a food supplement (33,3 %) to 0,450 kg galacto-oligosaccharide/kg of a food supplement (45,0 %) for the general population, excluding infants and young children. |
| --- | --- |

(5)

Commission Implementing Regulation (EU) 2021/900 (5) authorised a change of the conditions of use of the novel food galacto-oligosaccharide. In particular, the use level of the novel food galacto-oligosaccharide in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (6) was increased from 0,333 kg galacto-oligosaccharide/kg of a food supplement (33,3 %) to 0,450 kg galacto-oligosaccharide/kg of a food supplement (45,0 %) for the general population, excluding infants and young children.

| (6) | On 19 November 2019, the company Dairy Crest Ltd trading as Saputo Dairy UK (‘the applicant’) submitted an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 for an amendment of the conditions of use of the novel food galacto-oligosaccharide. The applicant requested to extend the use of galacto-oligosaccharide to dairy confectionary, cheese and processed cheese, butter and spreads intended for the general population. |
| --- | --- |

(6)

On 19 November 2019, the company Dairy Crest Ltd trading as Saputo Dairy UK (‘the applicant’) submitted an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 for an amendment of the conditions of use of the novel food galacto-oligosaccharide. The applicant requested to extend the use of galacto-oligosaccharide to dairy confectionary, cheese and processed cheese, butter and spreads intended for the general population.

| (7) | In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 21 December 2020, requesting it to provide a scientific opinion by carrying out an assessment of the proposed extension of use of the novel food galacto-oligosaccharide. |
| --- | --- |

(7)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 21 December 2020, requesting it to provide a scientific opinion by carrying out an assessment of the proposed extension of use of the novel food galacto-oligosaccharide.

| (8) | On 14 September 2021, the Authority adopted its scientific opinion on the ‘Safety of the extension of use of galacto-oligosaccharides as a Novel food pursuant to Regulation (EU) 2015/2283’ (7) in accordance with Article 11 of Regulation (EU) 2015/2283. |
| --- | --- |

(8)

On 14 September 2021, the Authority adopted its scientific opinion on the ‘Safety of the extension of use of galacto-oligosaccharides as a Novel food pursuant to Regulation (EU) 2015/2283’ (7) in accordance with Article 11 of Regulation (EU) 2015/2283.

| (9) | In its scientific opinion, the Authority concluded that the novel food that is composed of ≥ 57 % galacto-oligosaccharide dry matter, lactose and related saccharides, is safe under the proposed extension of use in dairy confectionary, cheese and processed cheese, butter and spreads, and therefore it is appropriate to amend the conditions of use of galacto-oligosaccharide. |
| --- | --- |

(9)

In its scientific opinion, the Authority concluded that the novel food that is composed of ≥ 57 % galacto-oligosaccharide dry matter, lactose and related saccharides, is safe under the proposed extension of use in dairy confectionary, cheese and processed cheese, butter and spreads, and therefore it is appropriate to amend the conditions of use of galacto-oligosaccharide.

| (10) | The information provided in the application and the Authority’s opinion gives sufficient grounds to establish that the proposed changes to the conditions of use of the novel food are in accordance with Article 9 and Article 12(1) of Regulation (EU) 2015/2283 and should be approved. |
| --- | --- |

(10)

The information provided in the application and the Authority’s opinion gives sufficient grounds to establish that the proposed changes to the conditions of use of the novel food are in accordance with Article 9 and Article 12(1) of Regulation (EU) 2015/2283 and should be approved.

| (11) | The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly. |
| --- | --- |

(11)

The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

| (12) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(12)

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

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

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

Done at Brussels, 28 April 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

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

2

(3)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel foods ingredients (OJ L 43, 14.2.1997, p. 1).

3

(4)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

4

(5)  Commission Implementing Regulation (EU) 2021/900 of 3 June 2021 authorising a change of the conditions of use of the novel food ‘galacto-oligosaccharide’ under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 197, 4.6.2021, p. 71).

5

(6)  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).

6

(7)  EFSA Journal 2021;19(10):6844.

7

---

ANNEX

| | In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘galacto-oligosaccharide’ is replaced by the following:











  ‘Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements | Data protection |
| --- | --- | --- | --- | --- | --- |
| Galacto-oligosaccharide | Specified food category | Maximum levels (expressed as ratio kg galacto-oligosaccharide/kg final food) | | | |
| Food supplements as defined in Directive 2002/46/EC | 0,333 |
| Food supplements as defined in Directive 2002/46/EC, excluding infants and young children | 0,450 (corresponding to 5,4  g galacto-oligosaccharide/serving; maximum 3 servings/day up to a maximum of 16,2  g/day) |
| Milk | 0,020 |
| Milk drinks | 0,030 |
| Meal replacement for weight control (as drinks) | 0,020 |
| Dairy analogue drinks | 0,020 |
| Yoghurt | 0,033 |
| Dairy based desserts | 0,043 |
| Frozen dairy desserts | 0,043 |
| Fruit drinks and energy drinks | 0,021 |
| Infant meal replacement drinks | 0,012 |
| Baby juice | 0,025 |
| Baby yogurt drink | 0,024 |
| Baby dessert | 0,027 |
| Baby snack | 0,143 |
| Baby cereals | 0,027 |
| Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen | 0,013 |
| Juice | 0,021 |
| Fruit pie filling | 0,059 |
| Fruit preparations | 0,125 |
| Bars | 0,125 |
| Cereals | 0,125 |
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | 0,008 |
| Dairy confectionery | 0,05 |
| Cheese and processed cheese | 0,1 |
| Butter and spreadable fats | 0,1 ’ |

In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘galacto-oligosaccharide’ is replaced by the following:

‘Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

Galacto-oligosaccharide

Specified food category

Maximum levels (expressed as ratio kg galacto-oligosaccharide/kg final food)

Food supplements as defined in Directive 2002/46/EC

0,333

Food supplements as defined in Directive 2002/46/EC, excluding infants and young children

0,450 (corresponding to 5,4  g galacto-oligosaccharide/serving; maximum 3 servings/day up to a maximum of 16,2  g/day)

Milk

0,020

Milk drinks

0,030

Meal replacement for weight control (as drinks)

0,020

Dairy analogue drinks

0,020

Yoghurt

0,033

Dairy based desserts

0,043

Frozen dairy desserts

0,043

Fruit drinks and energy drinks

0,021

Infant meal replacement drinks

0,012

Baby juice

0,025

Baby yogurt drink

0,024

Baby dessert

0,027

Baby snack

0,143

Baby cereals

0,027

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

0,013

Juice

0,021

Fruit pie filling

0,059

Fruit preparations

0,125

Bars

0,125

Cereals

0,125

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

0,008

Dairy confectionery

0,05

Cheese and processed cheese

0,1

Butter and spreadable fats

0,1 ’

---

| 29.4.2022 | EN | Official Journal of the European Union | L 126/14 |
| --- | --- | --- | --- |

29.4.2022

EN

Official Journal of the European Union

L 126/14

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/685

of 28 April 2022

amending Regulation (EC) No 333/2007 as regards the sampling requirements for fish and terrestrial animals

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (1), and in particular Article 34(6) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 333/2007 (2) lays down the methods of sampling and analysis to be used for the control of the levels of trace elements and processing contaminants in foodstuffs. |
| --- | --- |

(1)

Commission Regulation (EC) No 333/2007 (2) lays down the methods of sampling and analysis to be used for the control of the levels of trace elements and processing contaminants in foodstuffs.

| (2) | In Part B of the Annex to Regulation (EC) No 333/2007 specific provisions for the sampling of large fish arriving in large lots are established and pursuant to those the middle part of such fish is to be sampled. As this may have in some cases a high impact on the product, alternative sampling requirements need to be provided for, in order to allow also sampling at the head or the tail. Furthermore, uniform requirements need to be set on the part of the fish to be sampled, depending on different size of the fish, as such requirements ensure a better comparability of analytical results throughout the Union. |
| --- | --- |

(2)

In Part B of the Annex to Regulation (EC) No 333/2007 specific provisions for the sampling of large fish arriving in large lots are established and pursuant to those the middle part of such fish is to be sampled. As this may have in some cases a high impact on the product, alternative sampling requirements need to be provided for, in order to allow also sampling at the head or the tail. Furthermore, uniform requirements need to be set on the part of the fish to be sampled, depending on different size of the fish, as such requirements ensure a better comparability of analytical results throughout the Union.

| (3) | In relation to the amended sampling requirements for fish, also the definition of ‘lot’ should be amended and a definition of ‘comparable size or weight’ should be provided. |
| --- | --- |

(3)

In relation to the amended sampling requirements for fish, also the definition of ‘lot’ should be amended and a definition of ‘comparable size or weight’ should be provided.

| (4) | In Annex IV to Council Directive 96/23/EC (3) requirements are set out for the sampling of terrestrial animals and aquaculture products for the analysis of residues and contaminants. Directive 96/23/EC has been repealed by Regulation (EU) 2017/625, but under Article 150 of that Regulation, that Directive remains applicable until 14 December 2022. Taking into account the end of those transitional measures relating to the application of Directive 96/23/EC, such requirements need to be set out in Regulation (EC) No 333/2007 to apply from 15 December 2022. |
| --- | --- |

(4)

In Annex IV to Council Directive 96/23/EC (3) requirements are set out for the sampling of terrestrial animals and aquaculture products for the analysis of residues and contaminants. Directive 96/23/EC has been repealed by Regulation (EU) 2017/625, but under Article 150 of that Regulation, that Directive remains applicable until 14 December 2022. Taking into account the end of those transitional measures relating to the application of Directive 96/23/EC, such requirements need to be set out in Regulation (EC) No 333/2007 to apply from 15 December 2022.

| (5) | Regulation (EC) No 333/2007 should therefore be amended accordingly. |
| --- | --- |

(5)

Regulation (EC) No 333/2007 should therefore be amended accordingly.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(6)

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

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EC) No 333/2007 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.

The Annex shall apply from 15 December 2022.

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

Done at Brussels, 28 April 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 95, 7.4.2017, p. 1.

1

(2)  Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs (OJ L 88, 29.3.2007, p. 29).

2

(3)  Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10).

3

---

ANNEX

The Annex to Regulation (EC) No 333/2007 is amended as follows:

| (1) | Part A is amended as follows:






  (a) | the definition of ‘lot’ is replaced by the following:

  ‘
  “lot”: an identifiable quantity of food delivered at one time and determined by the official to have common characteristics (such as origin, variety, species, catchment area, type of packing, packer, consignor or markings);’; |
| --- | --- | --- |

(1)

Part A is amended as follows:

(a)

the definition of ‘lot’ is replaced by the following:

‘
  “lot”: an identifiable quantity of food delivered at one time and determined by the official to have common characteristics (such as origin, variety, species, catchment area, type of packing, packer, consignor or markings);’;

| (b) | the following definition is added:

  ‘
  “comparable size or weight”: the difference in size or weight does not exceed 50 %.’; |
| --- | --- |

(b)

the following definition is added:

‘
  “comparable size or weight”: the difference in size or weight does not exceed 50 %.’;

| (2) | Part B is amended as follows:






  (a) | point B.2.3 is replaced by the following:
  ‘B.2.3.   Specific provisions for the sampling of lots containing whole fish of comparable size or weight

  The number of incremental samples to be taken from the lot is set out in Table 3. The aggregate sample uniting all incremental samples shall be at least 1 kilogram (see point B.2.2).






  — | Where the lot to be sampled contains small fish (individual fish weighing < 1 kilogram), the whole fish is taken as incremental sample to form the aggregate sample. Where the resulting aggregate sample weighs more than 3 kilograms, the incremental samples may consist of the middle parts of the fish, weighing each at least 100 grams, forming the aggregate sample. The whole part to which the maximum level is applicable, is used for homogenisation of the sample.
  The middle part of the fish is where the centre of gravity is. This is located in most cases at the dorsal fin (in case the fish has a dorsal fin) or halfway between the gill opening and the anus. |
| --- | --- | --- | --- |

(2)

Part B is amended as follows:

(a)

point B.2.3 is replaced by the following:

‘B.2.3.   Specific provisions for the sampling of lots containing whole fish of comparable size or weight

The number of incremental samples to be taken from the lot is set out in Table 3. The aggregate sample uniting all incremental samples shall be at least 1 kilogram (see point B.2.2).

—

Where the lot to be sampled contains small fish (individual fish weighing < 1 kilogram), the whole fish is taken as incremental sample to form the aggregate sample. Where the resulting aggregate sample weighs more than 3 kilograms, the incremental samples may consist of the middle parts of the fish, weighing each at least 100 grams, forming the aggregate sample. The whole part to which the maximum level is applicable, is used for homogenisation of the sample.

The middle part of the fish is where the centre of gravity is. This is located in most cases at the dorsal fin (in case the fish has a dorsal fin) or halfway between the gill opening and the anus.

| — | Where the lot to be sampled contains larger fish (individual fish weighing ≥ 1 kilogram), the incremental sample consists of the middle part of the fish. Each incremental sample weighs at least 100 grams.
  For fish of intermediate size (≥ 1 kilogram and < 6 kilograms) the incremental sample is taken as a slice of the fish from backbone to belly in the middle part of the fish.
  For very large fish (≥ 6 kilograms), the incremental sample is taken from the right side (frontal view) dorso-lateral muscle meat in the middle part of the fish. Where the taking of such a piece of the middle part of the fish would result in a significant economic damage, the taking of three incremental samples of at least 350 grams each may be considered as being sufficient independent of the size of the lot or alternatively three incremental samples of at least 350 grams each from an equal part (175 grams) of the muscle meat close to the tail part and the muscle meat close to the head part of each fish may be considered as being sufficient independent of the size of the lot.’; |
| --- | --- |

—

Where the lot to be sampled contains larger fish (individual fish weighing ≥ 1 kilogram), the incremental sample consists of the middle part of the fish. Each incremental sample weighs at least 100 grams.

For fish of intermediate size (≥ 1 kilogram and < 6 kilograms) the incremental sample is taken as a slice of the fish from backbone to belly in the middle part of the fish.

For very large fish (≥ 6 kilograms), the incremental sample is taken from the right side (frontal view) dorso-lateral muscle meat in the middle part of the fish. Where the taking of such a piece of the middle part of the fish would result in a significant economic damage, the taking of three incremental samples of at least 350 grams each may be considered as being sufficient independent of the size of the lot or alternatively three incremental samples of at least 350 grams each from an equal part (175 grams) of the muscle meat close to the tail part and the muscle meat close to the head part of each fish may be considered as being sufficient independent of the size of the lot.’;

| (b) | the following points are added:
  ‘B.2.4.   Specific provisions for sampling of lots of fish containing whole fish of different size and/or weight

  The provisions of point B.2.3 as regards sample constitution shall apply.
  Where a size or weight class/category is predominant (about 80 % or more of the lot), the sample is taken from fish with the predominant size or weight. This sample is to be considered as being representative for the whole lot.
  Where no particular size or weight class/category predominates, then it shall be ensured that the fish selected for the sample are representative for the lot. Specific guidance for such cases is provided in “Guidance document on sampling of whole fish of different size and/or weight”
   (*1).
  B.2.5.   Specific provisions for the sampling of terrestrial animals

  For meat and offal of porcine, bovine, ovine, caprine and equine animals a sample of 1 kilogram shall be taken from at least one animal. If needed to obtain a sample quantity of 1 kilogram, equal sample quantities shall be taken from more than one animal.
  For poultry meat equal quantities shall be sampled from at least three animals in order to obtain an aggregate sample of 1 kilogram. For poultry offal equal quantities shall be sampled from at least three animals in order to obtain an aggregate sample of 300 grams.
  For meat and offal of farmed game animals and wild terrestrial animals a sample of 300 grams shall be taken from at least one animal. If needed to obtain a sample quantity of 300 grams, equal sample quantities shall be taken from more than one animal.

  (*1)  https://ec.europa.eu/food/safety/chemical-safety/contaminants/sampling-and-analysis’;" |
| --- | --- |

(b)

the following points are added:

‘B.2.4.   Specific provisions for sampling of lots of fish containing whole fish of different size and/or weight

The provisions of point B.2.3 as regards sample constitution shall apply.

Where a size or weight class/category is predominant (about 80 % or more of the lot), the sample is taken from fish with the predominant size or weight. This sample is to be considered as being representative for the whole lot.

Where no particular size or weight class/category predominates, then it shall be ensured that the fish selected for the sample are representative for the lot. Specific guidance for such cases is provided in “Guidance document on sampling of whole fish of different size and/or weight”
   (*1).

B.2.5.   Specific provisions for the sampling of terrestrial animals

For meat and offal of porcine, bovine, ovine, caprine and equine animals a sample of 1 kilogram shall be taken from at least one animal. If needed to obtain a sample quantity of 1 kilogram, equal sample quantities shall be taken from more than one animal.

For poultry meat equal quantities shall be sampled from at least three animals in order to obtain an aggregate sample of 1 kilogram. For poultry offal equal quantities shall be sampled from at least three animals in order to obtain an aggregate sample of 300 grams.

For meat and offal of farmed game animals and wild terrestrial animals a sample of 300 grams shall be taken from at least one animal. If needed to obtain a sample quantity of 300 grams, equal sample quantities shall be taken from more than one animal.

(*1)  https://ec.europa.eu/food/safety/chemical-safety/contaminants/sampling-and-analysis’;"

| (3) | point C.2.1 is replaced by the following:
  ‘C.2.1.   Precautions and general considerations

  The basic requirement is to obtain a representative and homogeneous laboratory sample without introducing secondary contamination.
  The whole part to which the maximum level is applicable shall be used for homogenisation of the sample.
  For products other than fish all of the sample material received by the laboratory shall be used for the preparation of the laboratory sample.
  For fish all of the sample material received by the laboratory shall be homogenised. From the homogenised aggregate sample, a representative part/ quantity shall be used for the preparation of the laboratory sample.
  Compliance with maximum levels laid down in Regulation (EC) No 1881/2006 shall be established on the basis of the levels determined in the laboratory samples.’ |
| --- | --- |

(3)

point C.2.1 is replaced by the following:

‘C.2.1.   Precautions and general considerations

The basic requirement is to obtain a representative and homogeneous laboratory sample without introducing secondary contamination.

The whole part to which the maximum level is applicable shall be used for homogenisation of the sample.

For products other than fish all of the sample material received by the laboratory shall be used for the preparation of the laboratory sample.

For fish all of the sample material received by the laboratory shall be homogenised. From the homogenised aggregate sample, a representative part/ quantity shall be used for the preparation of the laboratory sample.

Compliance with maximum levels laid down in Regulation (EC) No 1881/2006 shall be established on the basis of the levels determined in the laboratory samples.’

---

(*1)  https://ec.europa.eu/food/safety/chemical-safety/contaminants/sampling-and-analysis’;’

---

| 29.4.2022 | EN | Official Journal of the European Union | L 126/18 |
| --- | --- | --- | --- |

29.4.2022

EN

Official Journal of the European Union

L 126/18

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/686

of 28 April 2022

amending Implementing Regulations (EU) 2015/1295 and (EU) No 540/2011 as regards the conditions of approval of the active substance sulfoxaflor

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first alternative of Article 21(3) and Article 78(2) thereof,

Whereas:

| (1) | Commission Implementing Regulation (EU) 2015/1295 (2) provides for the approval of the active substance sulfoxaflor and the resulting insertion of sulfoxaflor in the Annex to Commission Implementing Regulation (EU) No 540/2011 (3). |
| --- | --- |

(1)

Commission Implementing Regulation (EU) 2015/1295 (2) provides for the approval of the active substance sulfoxaflor and the resulting insertion of sulfoxaflor in the Annex to Commission Implementing Regulation (EU) No 540/2011 (3).

| (2) | Implementing Regulation (EU) 2015/1295 also provides for the submission of further confirmatory information on the risk to honey bees via the different routes of exposure, in particular nectar, pollen, guttation fluid and dust, the risk to honey bees foraging for nectar or pollen in succeeding crops and flowering weeds, the risk to pollinators other than honey bees and the risk to bee brood. |
| --- | --- |

(2)

Implementing Regulation (EU) 2015/1295 also provides for the submission of further confirmatory information on the risk to honey bees via the different routes of exposure, in particular nectar, pollen, guttation fluid and dust, the risk to honey bees foraging for nectar or pollen in succeeding crops and flowering weeds, the risk to pollinators other than honey bees and the risk to bee brood.

| (3) | The applicant submitted the required confirmatory information within the period provided for in Implementing Regulation (EU) 2015/1295. |
| --- | --- |

(3)

The applicant submitted the required confirmatory information within the period provided for in Implementing Regulation (EU) 2015/1295.

| (4) | As agreed between Ireland and the Czech Republic, the rapporteur and the co-rapporteur Member State, the Czech Republic assessed the confirmatory information submitted by the applicant. The Czech Republic submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission, and the European Food Safety Authority (‘the Authority’) on 12 March 2018. |
| --- | --- |

(4)

As agreed between Ireland and the Czech Republic, the rapporteur and the co-rapporteur Member State, the Czech Republic assessed the confirmatory information submitted by the applicant. The Czech Republic submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission, and the European Food Safety Authority (‘the Authority’) on 12 March 2018.

| (5) | The Member States, the applicant and the Authority were consulted and asked to provide comments on the assessment of the confirmatory information by the co-rapporteur Member State. |
| --- | --- |

(5)

The Member States, the applicant and the Authority were consulted and asked to provide comments on the assessment of the confirmatory information by the co-rapporteur Member State.

| (6) | The Authority published a technical report (4) summarising the outcome of this consultation for sulfoxaflor on 20 September 2018. |
| --- | --- |

(6)

The Authority published a technical report (4) summarising the outcome of this consultation for sulfoxaflor on 20 September 2018.

| (7) | As divergent opinions were expressed during the consultation on the addendum to the draft assessment report, the Commission consulted the Authority and requested it to provide a conclusion on all points where there were divergent opinions. |
| --- | --- |

(7)

As divergent opinions were expressed during the consultation on the addendum to the draft assessment report, the Commission consulted the Authority and requested it to provide a conclusion on all points where there were divergent opinions.

| (8) | The Authority published its conclusion on the risk assessment on 28 March 2019 (5). The Commission further consulted the Authority in relation to the risk to bees. The Commission asked the Authority, in particular, to complete the assessment of the spray drift reducing measures necessary to protect bumblebees and solitary bees in field margins from exposure to sulfoxaflor and of the risk to bees from puddle water. |
| --- | --- |

(8)

The Authority published its conclusion on the risk assessment on 28 March 2019 (5). The Commission further consulted the Authority in relation to the risk to bees. The Commission asked the Authority, in particular, to complete the assessment of the spray drift reducing measures necessary to protect bumblebees and solitary bees in field margins from exposure to sulfoxaflor and of the risk to bees from puddle water.

| (9) | The Authority published its updated conclusion on 30 March 2020 (6). |
| --- | --- |

(9)

The Authority published its updated conclusion on 30 March 2020 (6).

| (10) | In its updated conclusion, the Authority considered that in the light of the outcome of the evaluation of the confirmatory information provided by the applicant, the risk to bees for uses in permanent greenhouses was acceptable. However, the assessment of the risk to bumble bees and solitary bees from outdoor uses could not be finalised. Therefore, the Authority could not conclude that there is a low risk to bumble bees and solitary bees from outdoor uses. |
| --- | --- |

(10)

In its updated conclusion, the Authority considered that in the light of the outcome of the evaluation of the confirmatory information provided by the applicant, the risk to bees for uses in permanent greenhouses was acceptable. However, the assessment of the risk to bumble bees and solitary bees from outdoor uses could not be finalised. Therefore, the Authority could not conclude that there is a low risk to bumble bees and solitary bees from outdoor uses.

| (11) | The draft assessment report, the addendum and the updated conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 28 January 2022. At the same time, the review report for sulfoxaflor was updated. |
| --- | --- |

(11)

The draft assessment report, the addendum and the updated conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 28 January 2022. At the same time, the review report for sulfoxaflor was updated.

| (12) | The applicant was given the possibility to submit comments on the updated review report. |
| --- | --- |

(12)

The applicant was given the possibility to submit comments on the updated review report.

| (13) | However, despite the arguments put forward by the applicant, the Commission has concluded that a risk to bees from outdoor uses of sulfoxaflor cannot be excluded. Consequently, in accordance with Article 21(3) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof, it is necessary and appropriate to restrict the approval of sulfoxaflor to uses in permanent greenhouses only. |
| --- | --- |

(13)

However, despite the arguments put forward by the applicant, the Commission has concluded that a risk to bees from outdoor uses of sulfoxaflor cannot be excluded. Consequently, in accordance with Article 21(3) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof, it is necessary and appropriate to restrict the approval of sulfoxaflor to uses in permanent greenhouses only.

| (14) | Implementing Regulations (EU) 2015/1295 and (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(14)

Implementing Regulations (EU) 2015/1295 and (EU) No 540/2011 should therefore be amended accordingly.

| (15) | Member States should be allowed sufficient time to withdraw or amend authorisations for plant protection products containing sulfoxaflor that do not comply with the restricted conditions of approval. |
| --- | --- |

(15)

Member States should be allowed sufficient time to withdraw or amend authorisations for plant protection products containing sulfoxaflor that do not comply with the restricted conditions of approval.

| (16) | For plant protection products containing sulfoxaflor, where Member States grant a grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should be as short as possible and expire no later than 12 months after the entry into force of this Regulation. |
| --- | --- |

(16)

For plant protection products containing sulfoxaflor, where Member States grant a grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should be as short as possible and expire no later than 12 months after the entry into force of this Regulation.

| (17) | In light of all the available pertinent information, it is considered inappropriate to maintain the approval of the active substance for outdoor use at this time. However, this Regulation does not prevent the applicant from submitting additional information to amend the conditions of approval, as provided in Articles 7 and 14 of Regulation (EC) No 1107/2009, and that information will be reviewed within a reasonable period of time as provided for in that Regulation. |
| --- | --- |

(17)

In light of all the available pertinent information, it is considered inappropriate to maintain the approval of the active substance for outdoor use at this time. However, this Regulation does not prevent the applicant from submitting additional information to amend the conditions of approval, as provided in Articles 7 and 14 of Regulation (EC) No 1107/2009, and that information will be reviewed within a reasonable period of time as provided for in that Regulation.

| (18) | The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion, |
| --- | --- |

(18)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

HAS ADOPTED THIS REGULATION:

Article 1

Amendment to Implementing Regulation (EU) 2015/1295

Annex I to Implementing Regulation (EU) 2015/1295 is amended in accordance with Annex I to this Regulation.

Article 2

Amendment to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex II to this Regulation.

Article 3

Transitional measures

Member States shall, where necessary, withdraw or amend authorisations for plant protection products containing sulfoxaflor as active substance by 19 November 2022 at the latest.

Article 4

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall expire by 19 May 2023 at the latest.

Article 5

Entry into force

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

Official Journal of the European Union

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

Done at Brussels, 28 April 2022.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 309, 24.11.2009, p. 1.

1

(2)  Commission Implementing Regulation (EU) 2015/1295 of 27 July 2015 approving the active substance sulfoxaflor, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 199, 29.7.2015, p. 8).

2

(3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

3

(4)  EFSA (European Food Safety Authority), 2018. Technical report on the outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data. EFSA supporting publication 2018:EN-1474, 73 pp.

4

(5)  EFSA (European Food Safety Authority), 2019. Conclusion on the peer review of the pesticide risk assessment for the active substance sulfoxaflor in light of confirmatory data submitted. EFSA Journal 2019;17(3):5633, 14 pp.

5

(6)  EFSA (European Food Safety Authority), 2020. Conclusion on the peer review of the pesticide risk assessment for the active substance sulfoxaflor in light of confirmatory data submitted. EFSA Journal 2020;18(3):6056, 15 pp.

6

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ANNEX I

In Annex I to Implementing Regulation (EU) 2015/1295, the text of the column ‘Specific provisions’ is replaced by the following:

‘Only uses in permanent greenhouses may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulfoxaflor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 29 May 2015 and updated on 28 January 2022, shall be taken into account.

In this overall assessment, Member States shall pay particular attention to the risk to bees and bumble bees released for pollination, when products containing the substance are applied in greenhouses.

Conditions of use shall include risk mitigation measures, where appropriate.’

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ANNEX II

The text of the column ‘Specific provisions’ of row 88, sulfoxaflor, in Part B of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:

‘Only uses in permanent greenhouses may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulfoxaflor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 29 May 2015 and updated on 28 January 2022, shall be taken into account.

In this overall assessment, Member States shall pay particular attention to the risk to bees and bumble bees released for pollination, when products containing the substance are applied in greenhouses.

Conditions of use shall include risk mitigation measures, where appropriate.’

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DECISIONS

| 29.4.2022 | EN | Official Journal of the European Union | L 126/23 |
| --- | --- | --- | --- |

29.4.2022

EN

Official Journal of the European Union

L 126/23

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DECISION (EU) 2022/687 OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES

of 27 April 2022

appointing Judges to the General Court

THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 19 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 254 and 255 thereof,

Whereas:

| (1) | The terms of office of 26 Judges of the General Court are due to expire on 31 August 2022. Appointments to those posts should therefore be made for the period from 1 September 2022 to 31 August 2028. |
| --- | --- |

(1)

The terms of office of 26 Judges of the General Court are due to expire on 31 August 2022. Appointments to those posts should therefore be made for the period from 1 September 2022 to 31 August 2028.

| (2) | It has been proposed that the terms of office of Ms Maria José COSTEIRA, Mr Ricardo DA SILVA PASSOS, Mr Geert DE BAERE, Mr Sten FRIMODT NIELSEN, Mr Krisztián KECSMÁR, Mr Paul NIHOUL, Mr Jesper SVENNINGSEN and Mr Marc VAN DER WOUDE as Judges of the General Court be renewed. |
| --- | --- |

(2)

It has been proposed that the terms of office of Ms Maria José COSTEIRA, Mr Ricardo DA SILVA PASSOS, Mr Geert DE BAERE, Mr Sten FRIMODT NIELSEN, Mr Krisztián KECSMÁR, Mr Paul NIHOUL, Mr Jesper SVENNINGSEN and Mr Marc VAN DER WOUDE as Judges of the General Court be renewed.

| (3) | Mr Goulielmos VALASIDIS has been nominated for a first term of office as Judge of the General Court. |
| --- | --- |

(3)

Mr Goulielmos VALASIDIS has been nominated for a first term of office as Judge of the General Court.

| (4) | The panel set up under Article 255 of the Treaty on the Functioning of the European Union has given a favourable opinion on the suitability of those candidates to perform the duties of Judge of the General Court, |
| --- | --- |

(4)

The panel set up under Article 255 of the Treaty on the Functioning of the European Union has given a favourable opinion on the suitability of those candidates to perform the duties of Judge of the General Court,

HAVE ADOPTED THIS DECISION:

Article 1

The following are hereby appointed Judges to the General Court for the period from 1 September 2022 to 31 August 2028:

| — | Ms Maria José COSTEIRA, |
| --- | --- |

—

Ms Maria José COSTEIRA,

| — | Mr Ricardo DA SILVA PASSOS, |
| --- | --- |

—

Mr Ricardo DA SILVA PASSOS,

| — | Mr Geert DE BAERE, |
| --- | --- |

—

Mr Geert DE BAERE,

| — | Mr Sten FRIMODT NIELSEN, |
| --- | --- |

—

Mr Sten FRIMODT NIELSEN,

| — | Mr Krisztián KECSMÁR, |
| --- | --- |

—

Mr Krisztián KECSMÁR,

| — | Mr Paul NIHOUL, |
| --- | --- |

—

Mr Paul NIHOUL,

| — | Mr Jesper SVENNINGSEN, |
| --- | --- |

—

Mr Jesper SVENNINGSEN,

| — | Mr Goulielmos VALASIDIS, |
| --- | --- |

—

Mr Goulielmos VALASIDIS,

| — | Mr Marc VAN DER WOUDE. |
| --- | --- |

—

Mr Marc VAN DER WOUDE.

Article 2

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

Done at Brussels, 27 April 2022.

The President

P. LÉGLISE-COSTA

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GUIDELINES

| 29.4.2022 | EN | Official Journal of the European Union | L 126/25 |
| --- | --- | --- | --- |

29.4.2022

EN

Official Journal of the European Union

L 126/25

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GUIDELINE (EU) 2022/688 OF THE EUROPEAN CENTRAL BANK

of 22 April 2022

amending Guideline 2013/47/EU on a Trans-European Automated Real-time Gross settlement Express Transfer system (TARGET2) (ECB/2012/27) (ECB/2022/20)

THE GOVERNING COUNCIL OF THE EUROPEAN CENTRAL BANK,

Having regard to the Treaty on the Functioning of the European Union and in particular the first and fourth indents of Article 127(2) thereof,

Having regard to the Statute of the European System of Central Banks and of the European Central Bank, and in particular Article 3.1 and Articles 17, 18 and 22 thereof,

Whereas:

| (1) | On 20 July 2021, the Governing Council adopted Guideline (EU) 2021/1759 of the European Central Bank (ECB/2021/30) (1), which amended the rules in Guideline 2013/47/EU of the European Central Bank (ECB/2012/27) (2) applying to contracts concluded with T2S network service providers due to the implementation of the T2-T2S Consolidation Project. The amended rules introduced by Guideline (EU) 2021/1759 (ECB/2021/30) apply as of 13 June 2022. |
| --- | --- |

(1)

On 20 July 2021, the Governing Council adopted Guideline (EU) 2021/1759 of the European Central Bank (ECB/2021/30) (1), which amended the rules in Guideline 2013/47/EU of the European Central Bank (ECB/2012/27) (2) applying to contracts concluded with T2S network service providers due to the implementation of the T2-T2S Consolidation Project. The amended rules introduced by Guideline (EU) 2021/1759 (ECB/2021/30) apply as of 13 June 2022.

| (2) | Due to the unexpected efforts required to establish and stabilise the new connectivity with the Eurosystem Single Market Infrastructure Gateway, the application of those amended rules should be deferred for a period of three weeks, so that they apply as of 4 July 2022. |
| --- | --- |

(2)

Due to the unexpected efforts required to establish and stabilise the new connectivity with the Eurosystem Single Market Infrastructure Gateway, the application of those amended rules should be deferred for a period of three weeks, so that they apply as of 4 July 2022.

| (3) | Therefore, Guideline 2013/47/EU (ECB/2012/27) should be amended accordingly. |
| --- | --- |

(3)

Therefore, Guideline 2013/47/EU (ECB/2012/27) should be amended accordingly.

| (4) | In order to provide sufficient time for the central banks to take the necessary measures to comply with this Guideline, this Guideline should take effect on the date of notification and should be published without delay in the Official Journal of the European Union, |
| --- | --- |

(4)

In order to provide sufficient time for the central banks to take the necessary measures to comply with this Guideline, this Guideline should take effect on the date of notification and should be published without delay in the Official Journal of the European Union,

HAS ADOPTED THIS GUIDELINE:

Article 1

Amendment

The following new Article 34b is inserted in Annex IIA to Guideline 2013/47/EU (ECB/2012/27):

‘Article 34b

Deferred application of amendments introduced by paragraphs 1(c), 7 and 9 of Annex II to Guideline (EU) 2021/1759 (ECB/2021/30)

The necessary measures to be taken and applied from 13 June 2022 pursuant to Article 2(2) of Guideline (EU) 2021/1759 of the European Central Bank (ECB/2021/30) (*1) shall be applied from 4 July 2022.

Article 2

Taking effect and implementation

This Guideline shall take effect on the day of its notification to the national central banks of the Member States whose currency is the euro.

Article 3

Addressees

This Guideline is addressed to all Eurosystem central banks.

Done at Frankfurt am Main, 22 April 2022.

For the Governing Council of the ECB

The President of the ECB

Christine LAGARDE

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(1)  Guideline (EU) 2021/1759 of the European Central Bank of 20 July 2021 amending Guideline ECB/2012/27 on a Trans-European Automated Real-time Gross settlement Express Transfer system (TARGET2) (ECB/2021/30) (OJ L 354, 6.10.2021, p. 45).

1

(2)  Guideline 2013/47/EU of the European Central Bank of 5 December 2012 on a Trans-European Automated Real-time Gross settlement Express Transfer system (TARGET2) (ECB/2012/27) (OJ L 30, 30.1.2013, p. 1).

2

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