# Official Journal L 71/2023

| | ISSN 1977-0677 |
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| Official Journal
  of the European Union | L 71 |
| | |
| English edition | Legislation | Volume 669 March 2023 |

ISSN 1977-0677

Official Journal

of the European Union

L 71

English edition

Legislation

Volume 669 March 2023

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2023/511 of 24 November 2022 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for the calculation of risk-weighted exposure amounts of collective investment undertakings under the mandate-based approach (
  1
  ) | 1 |
| | * | Commission Implementing Regulation (EU) 2023/512 of 2 March 2023 approving a non-minor amendment to the product specification for a name entered in the register of protected designations of origin and protected geographical indications (Aceto Balsamico di Modena (PGI)) | 4 |
| | * | Commission Implementing Regulation (EU) 2023/513 of 8 March 2023 amending Annexes XV and XIX to Implementing Regulation (EU) 2021/404 as regards the list of third countries, territories or zones thereof authorised for the entry into the Union of meat products from ungulates, poultry and game birds and of eggs and egg products (
  1
  ) | 8 |
| | * | Commission Implementing Regulation (EU) 2023/514 of 8 March 2023 amending Implementing Regulation (EU) 2021/405 as regards highly refined products, the list of third countries with an approved control plan and the inclusion of Moldova in the list of third countries authorised for the entry into the Union of consignments of eggs intended for placing on the market as Class A eggs (
  1
  ) | 11 |
| | * | Commission Implementing Regulation (EU) 2023/515 of 8 March 2023 renewing the approval of the active substance abamectin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (
  1
  ) | 22 |
| | * | Commission Implementing Regulation (EU) 2023/516 of 8 March 2023 amending Implementing Regulation (EU) 2020/2236 as regards the model animal health certificate for the entry into the Union of consignments of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption (
  1
  ) | 27 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Delegated Regulation (EU) 2023/511 of 24 November 2022 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for the calculation of risk-weighted exposure amounts of collective investment undertakings under the mandate-based approach (
  1
  )

1

1

*

Commission Implementing Regulation (EU) 2023/512 of 2 March 2023 approving a non-minor amendment to the product specification for a name entered in the register of protected designations of origin and protected geographical indications (Aceto Balsamico di Modena (PGI))

4

*

Commission Implementing Regulation (EU) 2023/513 of 8 March 2023 amending Annexes XV and XIX to Implementing Regulation (EU) 2021/404 as regards the list of third countries, territories or zones thereof authorised for the entry into the Union of meat products from ungulates, poultry and game birds and of eggs and egg products (
  1
  )

1

8

*

Commission Implementing Regulation (EU) 2023/514 of 8 March 2023 amending Implementing Regulation (EU) 2021/405 as regards highly refined products, the list of third countries with an approved control plan and the inclusion of Moldova in the list of third countries authorised for the entry into the Union of consignments of eggs intended for placing on the market as Class A eggs (
  1
  )

1

11

*

Commission Implementing Regulation (EU) 2023/515 of 8 March 2023 renewing the approval of the active substance abamectin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (
  1
  )

1

22

*

Commission Implementing Regulation (EU) 2023/516 of 8 March 2023 amending Implementing Regulation (EU) 2020/2236 as regards the model animal health certificate for the entry into the Union of consignments of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption (
  1
  )

1

27

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices ( OJ L 20, 31.1.2022 ) | 37 |
| | * | Corrigendum to Council Implementing Regulation (EU) 2023/419 of 24 February 2023 implementing Article 8a of Regulation (EC) No 765/2006 concerning restrictive measures in view of the situation in Belarus and the involvement of Belarus in the Russian aggression against Ukraine ( OJ L 61, 27.2.2023 ) | 42 |
| | * | Corrigendum to Commission Regulation (EU) 2023/466 of 3 March 2023 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, novaluron and tetraconazole in or on certain products ( OJ L 68, 6.3.2023 ) | 43 |

Corrigenda

*

Corrigendum to Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices ( OJ L 20, 31.1.2022 )

( OJ L 20, 31.1.2022 )

37

*

Corrigendum to Council Implementing Regulation (EU) 2023/419 of 24 February 2023 implementing Article 8a of Regulation (EC) No 765/2006 concerning restrictive measures in view of the situation in Belarus and the involvement of Belarus in the Russian aggression against Ukraine ( OJ L 61, 27.2.2023 )

( OJ L 61, 27.2.2023 )

42

*

Corrigendum to Commission Regulation (EU) 2023/466 of 3 March 2023 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, novaluron and tetraconazole in or on certain products ( OJ L 68, 6.3.2023 )

( OJ L 68, 6.3.2023 )

43

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| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

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

| 9.3.2023 | EN | Official Journal of the European Union | L 71/1 |
| --- | --- | --- | --- |

9.3.2023

EN

Official Journal of the European Union

L 71/1

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COMMISSION DELEGATED REGULATION (EU) 2023/511

of 24 November 2022

supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards for the calculation of risk-weighted exposure amounts of collective investment undertakings under the mandate-based approach

(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 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and amending Regulation (EU) No 648/2012 (1), and in particular Article 132a(4), third subparagraph, thereof,

Whereas:

| (1) | In order to avoid undue variability in capital requirements across institutions, and to make the mandate-based approach operational in situations where there is insufficient information, it is necessary to specify the method for calculating the risk-weighted exposure amount for a collective investment undertaking (CIU) under the mandate-based approach for the cases where missing inputs do not allow for the computation of the risk weighted exposure amount. |
| --- | --- |

(1)

In order to avoid undue variability in capital requirements across institutions, and to make the mandate-based approach operational in situations where there is insufficient information, it is necessary to specify the method for calculating the risk-weighted exposure amount for a collective investment undertaking (CIU) under the mandate-based approach for the cases where missing inputs do not allow for the computation of the risk weighted exposure amount.

| (2) | Where a CIU enters into derivative transactions and the underlyings of the derivatives or the underlying risk of the derivatives’ positions are unknown, the replacement cost of the positions cannot be determined by institutions, therefore neither can their exposure value. In that case, institutions should base their calculations on the notional amount of a derivative’s position, which would usually be known and would be the best indicator of the size of the position, therefore providing an approximation for the exposure value. |
| --- | --- |

(2)

Where a CIU enters into derivative transactions and the underlyings of the derivatives or the underlying risk of the derivatives’ positions are unknown, the replacement cost of the positions cannot be determined by institutions, therefore neither can their exposure value. In that case, institutions should base their calculations on the notional amount of a derivative’s position, which would usually be known and would be the best indicator of the size of the position, therefore providing an approximation for the exposure value.

| (3) | Where the CIU’s mandate does not exclude entering into derivatives but does not include sufficient information to determine whether an underlying constitutes an on- or off-balance sheet exposure, it cannot be excluded that such an exposure is constituted. It is therefore necessary to include that exposure in the calculation of the risk-weighted exposure amounts of the CIU’s exposures. |
| --- | --- |

(3)

Where the CIU’s mandate does not exclude entering into derivatives but does not include sufficient information to determine whether an underlying constitutes an on- or off-balance sheet exposure, it cannot be excluded that such an exposure is constituted. It is therefore necessary to include that exposure in the calculation of the risk-weighted exposure amounts of the CIU’s exposures.

| (4) | Where the mandate does not provide sufficient information about the exposure value of such position, it cannot be excluded that the exposure value is the full notional amount of the derivative position. |
| --- | --- |

(4)

Where the mandate does not provide sufficient information about the exposure value of such position, it cannot be excluded that the exposure value is the full notional amount of the derivative position.

| (5) | Where the mandate does not specify the notional amount of the derivative position, to ensure a sufficiently prudent approach, that amount should be derived from the maximum notional amount of derivatives allowed under the mandate. |
| --- | --- |

(5)

Where the mandate does not specify the notional amount of the derivative position, to ensure a sufficiently prudent approach, that amount should be derived from the maximum notional amount of derivatives allowed under the mandate.

| (6) | Where the replacement costs or the potential future exposure for the purposes of calculating the exposure amount associated with counterparty credit risk are unknown, institutions should base their calculations on the sum of notional amounts of the transactions in the netting set, which would be the best available conservative estimate to allow for the use of the mandate-based approach. |
| --- | --- |

(6)

Where the replacement costs or the potential future exposure for the purposes of calculating the exposure amount associated with counterparty credit risk are unknown, institutions should base their calculations on the sum of notional amounts of the transactions in the netting set, which would be the best available conservative estimate to allow for the use of the mandate-based approach.

| (7) | There are cases in which it is not possible for institutions to ascertain the relevant netting sets for a certain type of derivative in the CIU, since there is no information available on the counterparties or on whether the transactions are subject to a legally enforceable bilateral netting arrangement referred to in Article 272, point (4), of Regulation (EU) No 575/2013. In those cases, institutions should assume that neither netting effects nor counterparty diversification exist for that type of derivative. Therefore, institutions should assume that the CIU has entered into a single derivative with the maximum notional amount allowed by the mandate for that type of derivative. |
| --- | --- |

(7)

There are cases in which it is not possible for institutions to ascertain the relevant netting sets for a certain type of derivative in the CIU, since there is no information available on the counterparties or on whether the transactions are subject to a legally enforceable bilateral netting arrangement referred to in Article 272, point (4), of Regulation (EU) No 575/2013. In those cases, institutions should assume that neither netting effects nor counterparty diversification exist for that type of derivative. Therefore, institutions should assume that the CIU has entered into a single derivative with the maximum notional amount allowed by the mandate for that type of derivative.

| (8) | This Regulation is based on the draft regulatory technical standards submitted to the Commission by the European Banking Authority. |
| --- | --- |

(8)

This Regulation is based on the draft regulatory technical standards submitted to the Commission by the European Banking Authority.

| (9) | The European Banking Authority has conducted open public consultations on the draft regulatory technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the advice of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (2), |
| --- | --- |

(9)

The European Banking Authority has conducted open public consultations on the draft regulatory technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the advice of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (2),

HAS ADOPTED THIS REGULATION:

Article 1

Determination of the exposure value of a CIU’s derivatives’ positions where the underlying is unknown for the purposes of Article 132a(2) of Regulation (EU) No 575/2013

1.   When applying the mandate-based approach in accordance with Article 132a(2) of Regulation (EU) No 575/2013, where the CIU’s mandate does not exclude that the underlying of a CIU’s derivative position constitutes an on- or off-balance sheet exposure, but the exposure value or, in the case of off-balance sheet exposures, the applicable percentage pursuant to Article 111 of Regulation (EU) No 575/2013, is unknown, institutions shall use the full notional amount of the derivative position as the exposure value for the calculation of the risk-weighted exposure amounts.

2.   For the purposes of determining the exposure value as set out in paragraph 1, where the notional amount of the derivative positions is unknown, institutions shall use a conservative estimation based on the maximum notional amount of the derivatives allowed under a CIU’s mandate as the exposure value.

Article 2

Calculation of the exposure values for the counterparty credit risk of a netting set of a CIU’s derivatives’ positions

1.   When calculating the exposure value of a netting set for counterparty credit risk in accordance with the approaches set out in Part 3, Title II, Chapter 6, Sections 3, 4 or 5, where relevant, of Regulation (EU) No 575/2013, institutions shall apply the following:

| (a) | where the institution is not able to calculate the replacement cost of the netting set according to the relevant approach, due to missing inputs, that institution shall use the sum of notional amounts of all the derivatives in the netting set as the replacement cost; |
| --- | --- |

(a)

where the institution is not able to calculate the replacement cost of the netting set according to the relevant approach, due to missing inputs, that institution shall use the sum of notional amounts of all the derivatives in the netting set as the replacement cost;

| (b) | where the institution is not able to calculate the potential future exposure of the netting set according to the relevant approach, due to missing inputs, that institution shall replace it by 0,15 times the sum of notional amounts of all the derivatives in the netting set. |
| --- | --- |

(b)

where the institution is not able to calculate the potential future exposure of the netting set according to the relevant approach, due to missing inputs, that institution shall replace it by 0,15 times the sum of notional amounts of all the derivatives in the netting set.

2.   When calculating the exposure value for counterparty credit risk in accordance with paragraph 1, where the notional amount of the derivatives in the netting set is unknown, institutions shall use a conservative estimation based on the maximum notional amount of the derivatives allowed under a CIU’s mandate to determine the exposure value of that netting set.

3.   For the purposes of paragraphs 1 and 2, where it is not possible for institutions to ascertain the relevant netting sets for a certain type of derivative in the CIU, they shall assume that the CIU has entered into a single derivative with the maximum notional amount permitted by the mandate for that type of derivative.

Article 3

Entry into force

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

Official Journal of the European Union

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

Done at Brussels, 24 November 2022.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12).

2

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| 9.3.2023 | EN | Official Journal of the European Union | L 71/4 |
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9.3.2023

EN

Official Journal of the European Union

L 71/4

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/512

of 2 March 2023

approving a non-minor amendment to the product specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Aceto Balsamico di Modena’ (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(3)(b) thereof,

Whereas:

| (1) | Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, the application from Italy for approval of a non-minor amendment to the product specification of the Protected Geographical Indication ‘Aceto Balsamico di Modena’ was published in the Official Journal of the European Union (2). |
| --- | --- |

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, the application from Italy for approval of a non-minor amendment to the product specification of the Protected Geographical Indication ‘Aceto Balsamico di Modena’ was published in the Official Journal of the European Union (2).

| (2) | On 31 August 2021 the Commission received from Germany three notices of opposition and one reasoned statement. Two other reasoned statements of opposition from Germany were submitted on 11 October 2021. On 16 September 2021 the Commission received the fourth notice of opposition from an opponent based in Türkiye. The related reasoned statement of opposition was submitted on 16 November 2021. |
| --- | --- |

(2)

On 31 August 2021 the Commission received from Germany three notices of opposition and one reasoned statement. Two other reasoned statements of opposition from Germany were submitted on 11 October 2021. On 16 September 2021 the Commission received the fourth notice of opposition from an opponent based in Türkiye. The related reasoned statement of opposition was submitted on 16 November 2021.

| (3) | After examining the reasoned statements of opposition and founding them admissible, in accordance with Article 51(3) of Regulation (EU) No 1151/2012, the Commission, by letter of 10 December 2021, invited both Italy and Germany and Italy and the opponent from Türkiye to engage in appropriate consultations in view of reaching an agreement. |
| --- | --- |

(3)

After examining the reasoned statements of opposition and founding them admissible, in accordance with Article 51(3) of Regulation (EU) No 1151/2012, the Commission, by letter of 10 December 2021, invited both Italy and Germany and Italy and the opponent from Türkiye to engage in appropriate consultations in view of reaching an agreement.

| (4) | On 4 March 2021 Germany informed the Commission that one of the oppositions was withdrawn, but maintained by two other opponents from Germany. |
| --- | --- |

(4)

On 4 March 2021 Germany informed the Commission that one of the oppositions was withdrawn, but maintained by two other opponents from Germany.

| (5) | The consultations between Italy and Germany on one side and Italy and the opponent from Türkiye on the other ended without an agreement being reached. The Commission should therefore take a decision on the amendments in accordance with the procedure provided for in Article 52(3)(b) of Regulation (EU) No 1151/2012 taking into account the results of these consultations. |
| --- | --- |

(5)

The consultations between Italy and Germany on one side and Italy and the opponent from Türkiye on the other ended without an agreement being reached. The Commission should therefore take a decision on the amendments in accordance with the procedure provided for in Article 52(3)(b) of Regulation (EU) No 1151/2012 taking into account the results of these consultations.

| (6) | The opponents considered that the amendments to the product specification would result in non-compliance with the conditions laid down in Article 5(2) of Regulation (EU) No 1151/2012, notably for breaking the link between the product and the geographical area. To that end, alleged changes to the organoleptic characteristics of ‘Aceto Balsamico di Modena’, the change of the minimum total acidity for the aged product and a correction procedure for possible deviations from the parameters were questioned. These amendments were also contested as lowering the quality of ‘Aceto Balsamico di Modena’ and resulting in non-compliance with the requirements laid down for wine vinegars under point 17 of Part II of Annex VII to Regulation (EU) No 1308/2013 of the European Parliament and of the Council (3) establishing a common organisation of the markets in agricultural products (acidity of at least 60 grams per litre = at least 6 %). |
| --- | --- |

(6)

The opponents considered that the amendments to the product specification would result in non-compliance with the conditions laid down in Article 5(2) of Regulation (EU) No 1151/2012, notably for breaking the link between the product and the geographical area. To that end, alleged changes to the organoleptic characteristics of ‘Aceto Balsamico di Modena’, the change of the minimum total acidity for the aged product and a correction procedure for possible deviations from the parameters were questioned. These amendments were also contested as lowering the quality of ‘Aceto Balsamico di Modena’ and resulting in non-compliance with the requirements laid down for wine vinegars under point 17 of Part II of Annex VII to Regulation (EU) No 1308/2013 of the European Parliament and of the Council (3) establishing a common organisation of the markets in agricultural products (acidity of at least 60 grams per litre = at least 6 %).

| (7) | Moreover, the opponents alleged non-compliance with the minimum requirements for the content of the product specification, with regard to Article (7)(1)(g) of Regulation (EU) No 1151/2012, concerning the removal of indication of the control body for ‘Aceto Balsamico di Modena’. |
| --- | --- |

(7)

Moreover, the opponents alleged non-compliance with the minimum requirements for the content of the product specification, with regard to Article (7)(1)(g) of Regulation (EU) No 1151/2012, concerning the removal of indication of the control body for ‘Aceto Balsamico di Modena’.

| (8) | Furthermore, the opponents alleged that the existing scope of protection has been unduly extended and, thus, the registration of the amendments would jeopardise the existence of names, trade marks or products, including balsamic vinegars of other origins. This claim would, in particular, concern the alleged inclusion of the obligation of bottling in the demarcated area, an additional rule on shape of containers, as well as the introduction of isotopic ratio parameters. As a result, the opponents claim that the planned amendments allegedly prejudice the interests of the bottlers of ‘Aceto Balsamico di Modena’ and German producers of other vinegars. |
| --- | --- |

(8)

Furthermore, the opponents alleged that the existing scope of protection has been unduly extended and, thus, the registration of the amendments would jeopardise the existence of names, trade marks or products, including balsamic vinegars of other origins. This claim would, in particular, concern the alleged inclusion of the obligation of bottling in the demarcated area, an additional rule on shape of containers, as well as the introduction of isotopic ratio parameters. As a result, the opponents claim that the planned amendments allegedly prejudice the interests of the bottlers of ‘Aceto Balsamico di Modena’ and German producers of other vinegars.

| (9) | Finally, the opponents claimed that newly introduced reduction of minimum acidity could lead to confusion between ‘Aceto Balsamico di Modena’ PGI and ‘Aceto Balsamico Tradizionale di Modena’ PDO. |
| --- | --- |

(9)

Finally, the opponents claimed that newly introduced reduction of minimum acidity could lead to confusion between ‘Aceto Balsamico di Modena’ PGI and ‘Aceto Balsamico Tradizionale di Modena’ PDO.

| (10) | The Commission has assessed the arguments exposed in the reasoned statements of opposition from Germany and Türkiye in the light of the provisions of Regulation (EU) No 1151/2012, taking into account the results of the appropriate consultations carried out between the applicant and the opponents and it has concluded that the amendment to the product specification for the protected geographical indication ‘Aceto Balsamico di Modena’ should be approved. |
| --- | --- |

(10)

The Commission has assessed the arguments exposed in the reasoned statements of opposition from Germany and Türkiye in the light of the provisions of Regulation (EU) No 1151/2012, taking into account the results of the appropriate consultations carried out between the applicant and the opponents and it has concluded that the amendment to the product specification for the protected geographical indication ‘Aceto Balsamico di Modena’ should be approved.

| (11) | Italy claimed that the opponents had not demonstrated their legitimate interest in lodging the oppositions, as required by Article 51(1) of Regulation (EU) No 1151/2012, since the opponents contested amendments that were either not applied for or that did not result in trade and/or market barriers.
  In the context of the procedure applicable to applications for amendments to the specification that are not minor, any natural or legal person having a legitimate interest may lodge an opposition to the application for amendment submitted. In the present case, the risk of harm to the interests of the opponents was not considered as purely improbable, nor hypothetical and, therefore, it was concluded that the opponents demonstrated legitimate interest in lodging the oppositions. |
| --- | --- |

(11)

Italy claimed that the opponents had not demonstrated their legitimate interest in lodging the oppositions, as required by Article 51(1) of Regulation (EU) No 1151/2012, since the opponents contested amendments that were either not applied for or that did not result in trade and/or market barriers.

In the context of the procedure applicable to applications for amendments to the specification that are not minor, any natural or legal person having a legitimate interest may lodge an opposition to the application for amendment submitted. In the present case, the risk of harm to the interests of the opponents was not considered as purely improbable, nor hypothetical and, therefore, it was concluded that the opponents demonstrated legitimate interest in lodging the oppositions.

| (12) | The analysis of the reservations submitted by the opponents revealed that indeed some of the claims were made with regard to the elements in the product specification that in fact have not changed as a result of the present amendments, but that consisted of mere editorial changes. These editorial changes aimed at bringing the single document in line with Article 8(1)(c) of Regulation (EU) No 1151/2012 and better reflecting the conditions established in the product specification of ‘Aceto Balsamico di Modena’ PGI. This concerns, in particular, the alleged changes to the organoleptic characteristics, the alleged changes concerning the use of additives and the use of plastic containers, as well as alleged obligation of bottling in the demarcated area. These rules have not changed, while the rewording that appeared in the single document and might have been perceived as amendments to the product specification, in fact resulted from the rectification of discrepancies between the product specification and the summary of the product specification that was published the Official Journal of the European Union (4). The Commission’s assessment of the application for amendment of ‘Aceto Balsamico di Modena’ PGI has focussed on the substantial amendments applied for. |
| --- | --- |

(12)

The analysis of the reservations submitted by the opponents revealed that indeed some of the claims were made with regard to the elements in the product specification that in fact have not changed as a result of the present amendments, but that consisted of mere editorial changes. These editorial changes aimed at bringing the single document in line with Article 8(1)(c) of Regulation (EU) No 1151/2012 and better reflecting the conditions established in the product specification of ‘Aceto Balsamico di Modena’ PGI. This concerns, in particular, the alleged changes to the organoleptic characteristics, the alleged changes concerning the use of additives and the use of plastic containers, as well as alleged obligation of bottling in the demarcated area. These rules have not changed, while the rewording that appeared in the single document and might have been perceived as amendments to the product specification, in fact resulted from the rectification of discrepancies between the product specification and the summary of the product specification that was published the Official Journal of the European Union (4). The Commission’s assessment of the application for amendment of ‘Aceto Balsamico di Modena’ PGI has focussed on the substantial amendments applied for.

| (13) | The changes concerning a minimum percentage of acidity for the ‘invecchiato’ (aged) type from 6 % to 5,5 % or allowed correction procedure for possible deviations cannot be considered as negatively impacting the link between the product and its geographical origin. The reasons behind these amendments have been explained and duly justified in the publication of the application, while it is evident that the nature and scale of these amendments do not alter the essential characteristics of ‘Aceto Balsamico di Modena’ PGI and consequently cannot make the link disappear. |
| --- | --- |

(13)

The changes concerning a minimum percentage of acidity for the ‘invecchiato’ (aged) type from 6 % to 5,5 % or allowed correction procedure for possible deviations cannot be considered as negatively impacting the link between the product and its geographical origin. The reasons behind these amendments have been explained and duly justified in the publication of the application, while it is evident that the nature and scale of these amendments do not alter the essential characteristics of ‘Aceto Balsamico di Modena’ PGI and consequently cannot make the link disappear.

| (14) | Moreover, the similarity in the level of acidity does not have a capacity to create confusion between ‘Aceto Balsamico di Modena’ PGI and ‘Aceto Balsamico Tradizionale di Modena’ PDO or lead to the evocation of the latter. Even if products under both designations share certain characteristics, like the level of acidity, they are made of different raw materials and follow different production method and thus remain distinct. |
| --- | --- |

(14)

Moreover, the similarity in the level of acidity does not have a capacity to create confusion between ‘Aceto Balsamico di Modena’ PGI and ‘Aceto Balsamico Tradizionale di Modena’ PDO or lead to the evocation of the latter. Even if products under both designations share certain characteristics, like the level of acidity, they are made of different raw materials and follow different production method and thus remain distinct.

| (15) | Finally, ‘Aceto Balsamico di Modena’ PGI is not defined as a wine vinegar and thus not subject to the rules applicable to wine vinegars, in particular with regard to the minimum acidity. |
| --- | --- |

(15)

Finally, ‘Aceto Balsamico di Modena’ PGI is not defined as a wine vinegar and thus not subject to the rules applicable to wine vinegars, in particular with regard to the minimum acidity.

| (16) | With respect to the oppositions concerning the extension of the size range of the bottles, the amendment cannot be considered as imposing any limitations on the operators involved in packaging of ‘Aceto Balsamico di Modena’. On the contrary, allowing additional capacities of containers such as 0,100 l, 0,150 l, 0,200 l or 1,5 l can be considered as liberalising the conditions for bottling. A possible effect of an increased competition that might result from the marketing of ‘Aceto Balsamico di Modena’ in a wider range of bottle sizes would be in line with the founding principles of the EU competition policy and should not be considered as detrimental to the reputation of the ‘Aceto Balsamico di Modena’ PGI. |
| --- | --- |

(16)

With respect to the oppositions concerning the extension of the size range of the bottles, the amendment cannot be considered as imposing any limitations on the operators involved in packaging of ‘Aceto Balsamico di Modena’. On the contrary, allowing additional capacities of containers such as 0,100 l, 0,150 l, 0,200 l or 1,5 l can be considered as liberalising the conditions for bottling. A possible effect of an increased competition that might result from the marketing of ‘Aceto Balsamico di Modena’ in a wider range of bottle sizes would be in line with the founding principles of the EU competition policy and should not be considered as detrimental to the reputation of the ‘Aceto Balsamico di Modena’ PGI.

| (17) | The aim of the characteristics of the containers with a capacity of less than 0,250 litres included in section 3.5 of the single document is to ensure a minimum standard of uniformity among the bottles, in which the product will be sold. This packaging rule is not included in the description of the product, nor is elaborated with regard to the product specificity under the section of the single document devoted to the link and thus it cannot be considered as an essential feature of the presentation of the product. As these requirements are set only for new containers with a capacity of less than 0,250 litres, which were not allowed before the present amendment, the contested change will not negatively impact investments in containers already made by the bottlers of ‘Aceto Balsamico di Modena’ and consequently, it will not result in their economic loss. |
| --- | --- |

(17)

The aim of the characteristics of the containers with a capacity of less than 0,250 litres included in section 3.5 of the single document is to ensure a minimum standard of uniformity among the bottles, in which the product will be sold. This packaging rule is not included in the description of the product, nor is elaborated with regard to the product specificity under the section of the single document devoted to the link and thus it cannot be considered as an essential feature of the presentation of the product. As these requirements are set only for new containers with a capacity of less than 0,250 litres, which were not allowed before the present amendment, the contested change will not negatively impact investments in containers already made by the bottlers of ‘Aceto Balsamico di Modena’ and consequently, it will not result in their economic loss.

| (18) | Information regarding the control body has not been provided directly in the single document, as it is not required there in line with Annex I to Commission Implementing Regulation (EU) No 668/2014 (5). However, this information has been included in the product specification, as stipulated in Article 7(1)(g) of Regulation (EU) No 1151/2012. |
| --- | --- |

(18)

Information regarding the control body has not been provided directly in the single document, as it is not required there in line with Annex I to Commission Implementing Regulation (EU) No 668/2014 (5). However, this information has been included in the product specification, as stipulated in Article 7(1)(g) of Regulation (EU) No 1151/2012.

| (19) | With reference to the opponents’ objections to the required compliance with the isotopic ratio parameters, such parameters have been introduced to better detect possible adulteration of the wine vinegar and improve the control system for ‘Aceto Balsamico di Modena’. The verification of the isotopic ratio is in any event carried out at the production stage and thus affecting only producers of ‘Aceto Balsamico di Modena’. |
| --- | --- |

(19)

With reference to the opponents’ objections to the required compliance with the isotopic ratio parameters, such parameters have been introduced to better detect possible adulteration of the wine vinegar and improve the control system for ‘Aceto Balsamico di Modena’. The verification of the isotopic ratio is in any event carried out at the production stage and thus affecting only producers of ‘Aceto Balsamico di Modena’.

| (20) | Accordingly, the amendments to the product specification published in the Official Journal of the European Union regarding the name ‘Aceto Balsamico di Modena’ (PGI) should be approved. |
| --- | --- |

(20)

Accordingly, the amendments to the product specification published in the Official Journal of the European Union regarding the name ‘Aceto Balsamico di Modena’ (PGI) should be approved.

| (21) | The measures provided for in this Regulation are in accordance with the opinion of the Agricultural Product Quality Policy Committee, |
| --- | --- |

(21)

The measures provided for in this Regulation are in accordance with the opinion of the Agricultural Product Quality Policy Committee,

HAS ADOPTED THIS REGULATION:

Article 1

The amendments to the product specification published in the Official Journal of the European Union regarding the name ‘Aceto Balsamico di Modena’ (PGI) are hereby approved.

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, 2 March 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  
  OJ C 231, 16.6.2021, p. 11.

2

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

3

(4)  
  OJ C 152, 6.7.2007, p. 18 and Commission Regulation (EC) No 583/2009 of 3 July 2009 entering a name in the register of protected designations of origin and protected geographical indications [Aceto Balsamico di Modena (PGI)] (OJ L 175, 4.7.2009, p. 7).

4

(5)  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).

5

---

| 9.3.2023 | EN | Official Journal of the European Union | L 71/8 |
| --- | --- | --- | --- |

9.3.2023

EN

Official Journal of the European Union

L 71/8

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/513

of 8 March 2023

amending Annexes XV and XIX to Implementing Regulation (EU) 2021/404 as regards the list of third countries, territories or zones thereof authorised for the entry into the Union of meat products from ungulates, poultry and game birds and of eggs and egg products

(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 Article 230(1) thereof,

Whereas:

| (1) | Regulation (EU) 2016/429 lays down, inter alia, the animal health requirements for the entry into the Union of consignments of animals, germinal products and products of animal origin, and it applies from 21 April 2021. One of those animal health requirements is that those consignments must come from a third country or territory, or zone or compartment thereof listed in accordance with Article 230(1) of that Regulation. |
| --- | --- |

(1)

Regulation (EU) 2016/429 lays down, inter alia, the animal health requirements for the entry into the Union of consignments of animals, germinal products and products of animal origin, and it applies from 21 April 2021. One of those animal health requirements is that those consignments must come from a third country or territory, or zone or compartment thereof listed in accordance with Article 230(1) of that Regulation.

| (2) | Commission Delegated Regulation (EU) 2020/692 (2) supplements Regulation (EU) 2016/429 as regards the animal health requirements for the entry into the Union of consignments of certain species and categories of animals, germinal products and products of animal origin from third countries or territories, or zones or compartments thereof. Delegated Regulation (EU) 2020/692 provides that consignments of animals, germinal products and products of animal origin falling within its scope may only be permitted to enter into the Union if they come from a third country or territory, or zone or compartment thereof, listed for the particular species and categories of animals, germinal products and products of animal origin, in accordance with the animal health requirements laid down in that Delegated Regulation. |
| --- | --- |

(2)

Commission Delegated Regulation (EU) 2020/692 (2) supplements Regulation (EU) 2016/429 as regards the animal health requirements for the entry into the Union of consignments of certain species and categories of animals, germinal products and products of animal origin from third countries or territories, or zones or compartments thereof. Delegated Regulation (EU) 2020/692 provides that consignments of animals, germinal products and products of animal origin falling within its scope may only be permitted to enter into the Union if they come from a third country or territory, or zone or compartment thereof, listed for the particular species and categories of animals, germinal products and products of animal origin, in accordance with the animal health requirements laid down in that Delegated Regulation.

| (3) | Commission Implementing Regulation (EU) 2021/404 (3) lays down the lists of third countries or territories, or zones or compartments thereof, from which the entry into the Union of those species and categories of animals, germinal products and products of animal origin, that fall within the scope of Delegated Regulation (EU) 2020/692, is permitted. The lists and certain general rules concerning the lists are set out in Annexes I to XXII to that Implementing Regulation. |
| --- | --- |

(3)

Commission Implementing Regulation (EU) 2021/404 (3) lays down the lists of third countries or territories, or zones or compartments thereof, from which the entry into the Union of those species and categories of animals, germinal products and products of animal origin, that fall within the scope of Delegated Regulation (EU) 2020/692, is permitted. The lists and certain general rules concerning the lists are set out in Annexes I to XXII to that Implementing Regulation.

| (4) | Annex XV, Part 1 to Implementing Regulation (EU) 2021/404 sets out the list of third countries or territories, or zones thereof, authorised for entry into the Union of meat products from ungulates, poultry and game birds. Annex XIX, Part 1 to Implementing Regulation (EU) 2021/404 sets out the list of third countries or territories, or zones thereof, authorised for entry into the Union of consignments of eggs and egg products. |
| --- | --- |

(4)

Annex XV, Part 1 to Implementing Regulation (EU) 2021/404 sets out the list of third countries or territories, or zones thereof, authorised for entry into the Union of meat products from ungulates, poultry and game birds. Annex XIX, Part 1 to Implementing Regulation (EU) 2021/404 sets out the list of third countries or territories, or zones thereof, authorised for entry into the Union of consignments of eggs and egg products.

| (5) | Moldova has submitted an application to the Commission to be authorised for the entry into the Union of consignments of meat products of poultry other than ratites, and eggs, and provided guarantees regarding compliance, by that third country, with the requirements on the notification and reporting of the listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for poultry, and guarantees regarding compliance by that third country with the relevant Union animal health requirements or with equivalent requirements. Therefore, and taking into account the poultry health situation in Moldova, it is appropriate to include that third country in the lists set out in Annex XV, Part 1 and in Annex XIX, Part 1 to Implementing Regulation (EU) 2021/404 as regards meat products of poultry other than ratites and eggs. |
| --- | --- |

(5)

Moldova has submitted an application to the Commission to be authorised for the entry into the Union of consignments of meat products of poultry other than ratites, and eggs, and provided guarantees regarding compliance, by that third country, with the requirements on the notification and reporting of the listed diseases referred to in Annex I to Delegated Regulation (EU) 2020/692 relevant for poultry, and guarantees regarding compliance by that third country with the relevant Union animal health requirements or with equivalent requirements. Therefore, and taking into account the poultry health situation in Moldova, it is appropriate to include that third country in the lists set out in Annex XV, Part 1 and in Annex XIX, Part 1 to Implementing Regulation (EU) 2021/404 as regards meat products of poultry other than ratites and eggs.

| (6) | Annexes XV and XIX to Implementing Regulation (EU) 2021/404 should therefore be amended accordingly. |
| --- | --- |

(6)

Annexes XV and XIX to Implementing Regulation (EU) 2021/404 should therefore be amended accordingly.

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

(7)

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

HAS ADOPTED THIS REGULATION:

Article 1

Annexes XV and XIX to Implementing Regulation (EU) 2021/404 are 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, 8 March 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 84, 31.3.2016, p. 1.

1

(2)  Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379).

2

(3)  Commission Implementing Regulation (EU) 2021/404 of 24 March 2021 laying down the lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with Regulation (EU) 2016/429 of the European Parliament and of the Council (OJ L 114, 31.3.2021, p. 1).

3

---

ANNEX

Annexes XV and XIX to Implementing Regulation (EU) 2021/404 are amended as follows:

| (1) | In Annex XV, in Part 1, the following entry for Moldova is inserted between the entry for Morocco and the entry for Montenegro:


















  ‘MD

  Moldova | MD-0 | Not authorised | Not authorised | Not authorised | Not authorised | Not authorised | Not authorised | Not authorised | D | Not authorised | Not authorised | MPST’ | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(1)

In Annex XV, in Part 1, the following entry for Moldova is inserted between the entry for Morocco and the entry for Montenegro:

‘MD

Moldova

MD-0

Not authorised

Not authorised

Not authorised

Not authorised

Not authorised

Not authorised

Not authorised

D

Not authorised

Not authorised

MPST’

| (2) | In Annex XIX, in Part 1, the entry for Moldova is replaced by the following:












  ‘MD

  Moldova | MD-0 | Eggs | E | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Egg products | EP’ | | | | |

(2)

In Annex XIX, in Part 1, the entry for Moldova is replaced by the following:

‘MD

Moldova

MD-0

Eggs

E

Egg products

EP’

---

| 9.3.2023 | EN | Official Journal of the European Union | L 71/11 |
| --- | --- | --- | --- |

9.3.2023

EN

Official Journal of the European Union

L 71/11

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/514

of 8 March 2023

amending Implementing Regulation (EU) 2021/405 as regards highly refined products, the list of third countries with an approved control plan and the inclusion of Moldova in the list of third countries authorised for the entry into the Union of consignments of eggs intended for placing on the market as Class A eggs

(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 127(2) thereof,

Whereas:

| (1) | Commission Delegated Regulation (EU) 2022/2292 (2) supplements Regulation (EU) 2017/625 and aims to ensure that consignments of food-producing animals and certain goods intended for human consumption from third countries or regions thereof comply with certain Union food safety requirements or those recognised to be at least equivalent thereto. In particular, that Regulation identifies the animals and goods intended for human consumption that are subject to the requirement to come from a third country or region thereof which appears on the list referred to in Article 126(2)(a) of Regulation (EU) 2017/625. |
| --- | --- |

(1)

Commission Delegated Regulation (EU) 2022/2292 (2) supplements Regulation (EU) 2017/625 and aims to ensure that consignments of food-producing animals and certain goods intended for human consumption from third countries or regions thereof comply with certain Union food safety requirements or those recognised to be at least equivalent thereto. In particular, that Regulation identifies the animals and goods intended for human consumption that are subject to the requirement to come from a third country or region thereof which appears on the list referred to in Article 126(2)(a) of Regulation (EU) 2017/625.

| (2) | Article 7 of Delegated Regulation (EU) 2022/2292 provides that certain consignments of food-producing animals, products of animal origin and composite products are to enter the Union only from a third country included in the list of third countries approved for the entry into the Union of such consignments for human consumption. |
| --- | --- |

(2)

Article 7 of Delegated Regulation (EU) 2022/2292 provides that certain consignments of food-producing animals, products of animal origin and composite products are to enter the Union only from a third country included in the list of third countries approved for the entry into the Union of such consignments for human consumption.

| (3) | Commission Implementing Regulation (EU) 2021/405 (3) lays down a list of third countries or regions thereof authorised for the entry into the Union of consignments of certain highly refined products, intended for human consumption. |
| --- | --- |

(3)

Commission Implementing Regulation (EU) 2021/405 (3) lays down a list of third countries or regions thereof authorised for the entry into the Union of consignments of certain highly refined products, intended for human consumption.

| (4) | Since a recent amendment (4) of Regulation (EC) No 853/2004 of the European Parliament and of the Council (5), highly refined products also cover fat derivatives and food flavourings that are authorized in accordance with Regulation (EC) No 1334/2008 of the European Parliament and of the Council (6), subject to treatments excluding any public or animal health risk. Implementing Regulation (EU) 2021/405 should be amended to be consistent with this change. |
| --- | --- |

(4)

Since a recent amendment (4) of Regulation (EC) No 853/2004 of the European Parliament and of the Council (5), highly refined products also cover fat derivatives and food flavourings that are authorized in accordance with Regulation (EC) No 1334/2008 of the European Parliament and of the Council (6), subject to treatments excluding any public or animal health risk. Implementing Regulation (EU) 2021/405 should be amended to be consistent with this change.

| (5) | Azerbaijan has submitted a control plan, which covers roes and caviar. The plan provides sufficient guarantees and should therefore be approved. |
| --- | --- |

(5)

Azerbaijan has submitted a control plan, which covers roes and caviar. The plan provides sufficient guarantees and should therefore be approved.

| (6) | Lebanon has submitted a control plan, which covers honey. The plan provides sufficient guarantees and should therefore be approved. |
| --- | --- |

(6)

Lebanon has submitted a control plan, which covers honey. The plan provides sufficient guarantees and should therefore be approved.

| (7) | Isle of Man is listed in the table of Annex -I to Implementing Regulation (EU) 2021/405 for its export to the Union of ovine and caprine meat. However, Isle of Man has informed the Commission that it is no longer interested in exporting caprine meat to the Union. The entry for Isle of Man for ovine and caprine meat in that table of Annex -I to Implementing Regulation (EU) 2021/405 should therefore only cover ovine meat. |
| --- | --- |

(7)

Isle of Man is listed in the table of Annex -I to Implementing Regulation (EU) 2021/405 for its export to the Union of ovine and caprine meat. However, Isle of Man has informed the Commission that it is no longer interested in exporting caprine meat to the Union. The entry for Isle of Man for ovine and caprine meat in that table of Annex -I to Implementing Regulation (EU) 2021/405 should therefore only cover ovine meat.

| (8) | Japan is listed in the table of Annex -I to Implementing Regulation (EU) 2021/405 for their export to the Union of pork meat. However, Japan has informed the Commission that it is no longer interested in submitting a control plan for pork meat but intends to use only pork meat originating either from Member States or third countries from which such products are authorised for entry into the Union. Consequently, the entry for Japan for pork meat should be adapted accordingly in Annex -I to Implementing Regulation (EU) 2021/405. |
| --- | --- |

(8)

Japan is listed in the table of Annex -I to Implementing Regulation (EU) 2021/405 for their export to the Union of pork meat. However, Japan has informed the Commission that it is no longer interested in submitting a control plan for pork meat but intends to use only pork meat originating either from Member States or third countries from which such products are authorised for entry into the Union. Consequently, the entry for Japan for pork meat should be adapted accordingly in Annex -I to Implementing Regulation (EU) 2021/405.

| (9) | The United Kingdom is listed in the table of Annex -I to Implementing Regulation (EU) 2021/405 for their export to the Union of rabbit meat. However, the United Kingdom has informed the Commission that it is no longer interested to submit a control plan for rabbit meat but intends to use only rabbit meat originating either from Member States or third countries from which such products are authorised for entry into the Union. Consequently, the entry for United Kingdom for rabbit meat should be adapted accordingly in Annex -I to Implementing Regulation (EU) 2021/405. |
| --- | --- |

(9)

The United Kingdom is listed in the table of Annex -I to Implementing Regulation (EU) 2021/405 for their export to the Union of rabbit meat. However, the United Kingdom has informed the Commission that it is no longer interested to submit a control plan for rabbit meat but intends to use only rabbit meat originating either from Member States or third countries from which such products are authorised for entry into the Union. Consequently, the entry for United Kingdom for rabbit meat should be adapted accordingly in Annex -I to Implementing Regulation (EU) 2021/405.

| (10) | Thailand has not submitted to the Commission a control plan for milk. However, Thailand has provided guarantees to use only milk originating either from Member States or third countries from which milk is authorised for entry into the Union. It has also informed the Commission that such milk to be exported to the Union will not be limited to composite products containing processed milk products. Consequently, the entry for Thailand for milk should be adapted accordingly in Annex -I to Implementing Regulation (EU) 2021/405. |
| --- | --- |

(10)

Thailand has not submitted to the Commission a control plan for milk. However, Thailand has provided guarantees to use only milk originating either from Member States or third countries from which milk is authorised for entry into the Union. It has also informed the Commission that such milk to be exported to the Union will not be limited to composite products containing processed milk products. Consequently, the entry for Thailand for milk should be adapted accordingly in Annex -I to Implementing Regulation (EU) 2021/405.

| (11) | The United States of America has submitted a control plan, which covers casings. The plan provides sufficient guarantees and should therefore be approved. |
| --- | --- |

(11)

The United States of America has submitted a control plan, which covers casings. The plan provides sufficient guarantees and should therefore be approved.

| (12) | Rwanda is currently listed in the table of Annex -I to Implementing Regulation (EU) 2021/405 for honey and Colombia and Syria are listed for casings. As those third countries have not submitted to the Commission plans for the respective products, those entries should be deleted from the table in that Annex. |
| --- | --- |

(12)

Rwanda is currently listed in the table of Annex -I to Implementing Regulation (EU) 2021/405 for honey and Colombia and Syria are listed for casings. As those third countries have not submitted to the Commission plans for the respective products, those entries should be deleted from the table in that Annex.

| (13) | Moldova submitted a Salmonella control programme in flocks of laying hens in order to be authorised for the entry into the Union of class A eggs in accordance with Article 7 of Implementing Regulation (EU) 2021/405. That control programme was assessed with satisfaction by the Commission. The compliance related to the requirements on Salmonella control in accordance with Article 10(6) of Regulation (EC) No 2160/2003 of the European Parliament and of the Council (7) was double checked during the audit carried out by the Commission in April 2022 (8). Moldova should therefore be authorised for the entry into the Union of class A eggs. |
| --- | --- |

(13)

Moldova submitted a Salmonella control programme in flocks of laying hens in order to be authorised for the entry into the Union of class A eggs in accordance with Article 7 of Implementing Regulation (EU) 2021/405. That control programme was assessed with satisfaction by the Commission. The compliance related to the requirements on Salmonella control in accordance with Article 10(6) of Regulation (EC) No 2160/2003 of the European Parliament and of the Council (7) was double checked during the audit carried out by the Commission in April 2022 (8). Moldova should therefore be authorised for the entry into the Union of class A eggs.

| (14) | Implementing Regulation (EU) 2021/405 should therefore be amended accordingly. |
| --- | --- |

(14)

Implementing Regulation (EU) 2021/405 should therefore be amended accordingly.

| (15) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(15)

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

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Implementing Regulation (EU) 2021/405

Implementing Regulation (EU) 2021/405 is amended as follows:

| (1) | in Article 22, the introductory phrase is replaced by the following:

  ‘Consignments of highly refined products as described in Section XVI of Annex III to Regulation (EC) No 853/2004, intended for human consumption, shall only be authorised for the entry into the Union if they come from the following third countries or regions thereof:’; |
| --- | --- |

(1)

in Article 22, the introductory phrase is replaced by the following:

‘Consignments of highly refined products as described in Section XVI of Annex III to Regulation (EC) No 853/2004, intended for human consumption, shall only be authorised for the entry into the Union if they come from the following third countries or regions thereof:’;

| (2) | Annex -I is replaced by text set out in Annex I to this Regulation; |
| --- | --- |

(2)

Annex -I is replaced by text set out in Annex I to this Regulation;

| (3) | Annex IV is replaced by the text set out in Annex II to this Regulation. |
| --- | --- |

(3)

Annex IV is replaced by the text set out in Annex II to this Regulation.

Article 2

Entry into force and application

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, 8 March 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  Commission Delegated Regulation (EU) 2022/2292 of 6 September 2022 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of food-producing animals and certain goods intended for human consumption (OJ L 304, 24.11.2022, p. 1).

2

(3)  Commission Implementing Regulation (EU) 2021/405 of 24 March 2021 laying down the lists of third countries or regions thereof authorised for the entry into the Union of certain animals and goods intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (OJ L 114, 31.3.2021, p. 118).

3

(4)  Commission Delegated Regulation (EU) 2022/2258 of 9 September 2022 amending and correcting Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council on specific hygiene requirements for food of animal origin as regards fishery products, eggs and certain highly refined products, and amending Commission Delegated Regulation (EU) 2019/624 as regards certain bivalve molluscs (OJ L 299, 18.11.2022, p. 5).

4

(5)  Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).

5

(6)  Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34).

6

(7)  Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (OJ L 325, 12.12.2003, p. 1).

7

(8)  DG(SANTE)2021-7268 – final report available on https://ec.europa.eu/food/audits-analysis/audit-report/details/4533

8

---

ANNEX I

Annex -I to Implementing Regulation (EU) 2021/405 is replaced by the following:

‘ANNEX -I

List of third countries or regions thereof with approved control plans for certain food-producing animals and products of animal origin intended for human consumption, as referred to in Article 2a, Article 3, Article 6, first paragraph, Article 7, first paragraph, Article 10, second paragraph, Articles 11, 15, 16, 21 and Article 25, points (a) and (c)

| Country ISO Code | Third country (1) or regions thereof | Bovine | Ovine/caprine | Porcine | Equine | Poultry | Aquaculture (17) | Milk | Eggs | Rabbit | Wild game | Farmed game | Honey | Casings |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| AD | Andorra | X | X | Δ | X | | P | | | | | | X | |
| AE | United Arab Emirates | | | | | | Δ
  P | X (2)

  O | O | | | | X (3) | |
| AL | Albania | | X | | | | X (14)

  P | O | X | | | | | X |
| AM | Armenia | | | | | | X (14)

  P | O | O | | | | X | |
| AR | Argentina | X | X | | X | X | X (14)

  P | X | X | X | X | X | X | X |
| AU | Australia | X | X | | X | | X
  M | X | X | | X | X | X | X |
| AZE | Azerbaijan | | | | | | X (16)

  P | | | | | | | |
| BA | Bosnia and Herzegovina | X | X | X | | X | X (14)

  P | X | X | | | | X | |
| BD | Bangladesh | | | | | | X
  P | O | O | | | | | |
| BF | Burkina Faso | | | | | | | | | | | | X | |
| BJ | Benin | | | | | | | | | | | | X | |
| BN | Brunei | | | | | | X (15)

  P | O | O | | | | | |
| BR | Brazil | X | | | X | X | X
  P | O | O | | | | X | X |
| BW | Botswana | X | | | | | P | | | | | | | |
| BY | Belarus | | | | X (8) | | X (14)

  P | X | X | | | | X | X |
| BZ | Belize | | | | | | X (15)

  P | O | O | | | | | |
| CA | Canada | X | X | X | X | X | X
  M | X | X | X | X | X | X | |
| CH | Switzerland (7) | X | X | X | X | X | X (14)

  M | X | X | X | X | X | X | X |
| CL | Chile | X | X5 | X | | X | X (14)

  M | X | O | | X | | X | X |
| CM | Cameroon | | | | | | | | | | | | X | |
| CN | China | | | | | X | X
  P | O | X | X | | | X | X |
| CO | Colombia | | | | | | X
  P | X | Δ | | | | | |
| CR | Costa Rica | | | | | | X
  P | O | O | | | | | |
| CU | Cuba | | | | | | X (15)

  P | O | O | | | | X | |
| DO | Dominican Republic | | | | | | | | | | | | X | |
| EC | Ecuador | | | | | | X
  P | O | O | | | | | |
| EG | Egypt | | | | | | | | | | | | | X |
| ET | Ethiopia | | | | | | | | | | | | X | |
| FK | Falkland Islands | X | X (5) | | | | X (14)

  P | O | O | | | | | |
| FO | The Faroe Islands | | | | | | X (14)

  P | O | O | | | | | |
| GB | United Kingdom (6) | X | X | X | X | X | X (14)

  Δ
  M | X | X | Δ | X | X | X | X |
| GE | Georgia | | | | | | | | | | | | X | |
| GG | Guernsey | | | | | | O
  M | X | O | | | | | |
| GL | Greenland | | X (5) | | | | M | | | | | X | | |
| GT | Guatemala | | | | | | X (15)

  P | O | O | | | | X | |
| HK | Hong Kong | | | | | | Δ
  P | | Δ | | | | | |
| HN | Honduras | | | | | | X
  P | O | O | | | | | |
| ID | Indonesia | | | | | | X
  P | O | O | | | | | |
| IL | Israel (4) | | | | | X | X (14)

  P | X | X | | | | X | |
| IM | Isle of Man | X | X (5) | X | | | X (14)

  M | X | O | | | | X | |
| IN | India | | | | | O | X
  P | O | X | | | | X | X |
| IR | Iran | | | | | | X (15)

  X (16)

  P | O | O | | | | | X |
| JE | Jersey | X | | | | | M | X | O | | | | | |
| JM | Jamaica | | | | | | M | | | | | | X | |
| JP | Japan | X | | Δ | | X | X (14)

  M | X | X | | | | Δ | X |
| KE | Kenya | | | | | | X (14)

  P | O | O | | | | | |
| KR | South Korea | | | | | X | X
  M | O | O | | | | Δ | |
| LB | Lebanon | | | | | | | | | | | | X | X |
| LK | Sri Lanka | | | | | | X
  P | O | O | | | | | |
| MA | Morocco | | | | | X | X (14)

  Δ
  M | O | O | | | | | X |
| MD | Moldova | | | | | X | X (14)

  P | X | X | | | | X | |
| ME | Montenegro | X | X (5) | X | | X | X (14)

  P | X | X | | | | X | |
| MG | Madagascar | | | | | | X
  P | O | O | | | | X | |
| MK | North Macedonia | X | X | X | | X | X (14)

  P | X | X | | X | | X | |
| MM | Myanmar | | | | | | X
  P | O | O | | | | X | |
| MN | Mongolia | | | | | | | | | | | | | X |
| MU | Mauritius | | | | | | X (14)

  P | O | O | | | | Δ | |
| MX | Mexico | | | Δ | | | X
  P | O | X | | | | X | |
| MY | Malaysia | | | | | Δ | X
  P | O | O | | | | | |
| MZ | Mozambique | | | | | | X (15)

  P | O | O | | | | | |
| NA | Namibia | X | X (5) | | | | P | | | | X | | | |
| NC | New Caledonia | | | | | | X (15)

  P | O | O | | | X | X | |
| NG | Nigeria | | | | | | X (15)

  P | O | O | | | | | |
| NI | Nicaragua | | | | | | X (15)

  P | O | O | | | | X | |
| NZ | New Zealand | X | X | O | X | O | X (14)

  M | X | O | O | X | X | X | X |
| PA | Panama | | | | | | X
  P | O | O | | | | | |
| PE | Peru | | | | | | X
  M | O | O | | | | | |
| PH | Philippines | | | | | | X
  P | O | O | | | | | |
| PK | Pakistan | | | | | | | | | | | | | X |
| PM | Saint Pierre and Miquelon | | | | | X | P | | | | | | | |
| PN | Pitcairn Islands | | | | | | | | | | | | X | |
| PY | Paraguay | X | | | | | P | | | | | | | X |
| RS | Serbia | X | X | X | X (8) | X | X (14)

  P | X | X | X | X | | X | X |
| RU | Russia | X | X | X | | X | O
  P | X | X | | | X (9) | X | X |
| RW | Rwanda | | | | | | | | | | | | | |
| SA | Saudi Arabia | | | | | | X
  P | O | O | | | | | |
| SG | Singapore | Δ | Δ | Δ | X (10) | Δ | X (14)

  P | Δ | Δ | | X (10) | X (10) | | |
| SM | San Marino | X | | Δ | | | O
  P | X | O | | | | X | |
| SV | El Salvador | | | | | | | | | | | | X | |
| SY | Syria | | | | | | | | | | | | | |
| SZ | Eswatini | X | | | | | P | | | | | | | |
| TG | Togo | | | | | | | | | | | | X | |
| TH | Thailand | O | | O | | X | X
  M | Δ | Δ | | | | X | |
| TN | Tunisia | | | | | | X (14)

  M | O | O | | | | | X |
| TR | Türkiye | | | | | X | X (14)

  M | X | X | | | | X | X |
| TW | Taiwan | | | | | | X
  P | O | X | | | | X | |
| TZ | Tanzania | | | | | | X (15)

  P | O | O | | | | X | |
| UA | Ukraine | X | | X | | X | X (14)

  M | X | X | X | | | X | X |
| UG | Uganda | | | | | | | | | | | | X | |
| US | United States | X | X (11) | X | | X | X
  M | X | X | X | X | X | X | X |
| UY | Uruguay | X | X | | X | | X (14)

  M | X | O | | X | | X | X |
| UZ | Uzbekistan | | | | | | | | | | | | | X |
| VE | Venezuela | | | | | | X (15)

  P | O | O | | | | | |
| VN | Vietnam | | | | | | X
  M | O | O | | | | X | |
| WF | Wallis and Futuna | | | | | | | | | | | | X | |
| XK | Kosovo (12) | | | | | Δ | | | | | | | | |
| ZA | South Africa | | | | | | P | | | | X | X (13) | | |
| ZM | Zambia | | | | | | | | | | | | X | |

Country ISO Code

Third country (1) or regions thereof

Bovine

Ovine/caprine

Porcine

Equine

Poultry

Aquaculture (17)

Milk

Eggs

Rabbit

Wild game

Farmed game

Honey

Casings

AD

Andorra

X

X

Δ

X

P

X

AE

United Arab Emirates

Δ

P

X (2)

O

O

X (3)

AL

Albania

X

X (14)

P

O

X

X

AM

Armenia

X (14)

P

O

O

X

AR

Argentina

X

X

X

X

X (14)

P

X

X

X

X

X

X

X

AU

Australia

X

X

X

X

M

X

X

X

X

X

X

AZE

Azerbaijan

X (16)

P

BA

Bosnia and Herzegovina

X

X

X

X

X (14)

P

X

X

X

BD

Bangladesh

X

P

O

O

BF

Burkina Faso

X

BJ

Benin

X

BN

Brunei

X (15)

P

O

O

BR

Brazil

X

X

X

X

P

O

O

X

X

BW

Botswana

X

P

BY

Belarus

X (8)

X (14)

P

X

X

X

X

BZ

Belize

X (15)

P

O

O

CA

Canada

X

X

X

X

X

X

M

X

X

X

X

X

X

CH

Switzerland (7)

X

X

X

X

X

X (14)

M

X

X

X

X

X

X

X

CL

Chile

X

X5

X

X

X (14)

M

X

O

X

X

X

CM

Cameroon

X

CN

China

X

X

P

O

X

X

X

X

CO

Colombia

X

P

X

Δ

CR

Costa Rica

X

P

O

O

CU

Cuba

X (15)

P

O

O

X

DO

Dominican Republic

X

EC

Ecuador

X

P

O

O

EG

Egypt

X

ET

Ethiopia

X

FK

Falkland Islands

X

X (5)

X (14)

P

O

O

FO

The Faroe Islands

X (14)

P

O

O

GB

United Kingdom (6)

X

X

X

X

X

X (14)

Δ

M

X

X

Δ

X

X

X

X

GE

Georgia

X

GG

Guernsey

O

M

X

O

GL

Greenland

X (5)

M

X

GT

Guatemala

X (15)

P

O

O

X

HK

Hong Kong

Δ

P

Δ

HN

Honduras

X

P

O

O

ID

Indonesia

X

P

O

O

IL

Israel (4)

X

X (14)

P

X

X

X

IM

Isle of Man

X

X (5)

X

X (14)

M

X

O

X

IN

India

O

X

P

O

X

X

X

IR

Iran

X (15)

X (16)

P

O

O

X

JE

Jersey

X

M

X

O

JM

Jamaica

M

X

JP

Japan

X

Δ

X

X (14)

M

X

X

Δ

X

KE

Kenya

X (14)

P

O

O

KR

South Korea

X

X

M

O

O

Δ

LB

Lebanon

X

X

LK

Sri Lanka

X

P

O

O

MA

Morocco

X

X (14)

Δ

M

O

O

X

MD

Moldova

X

X (14)

P

X

X

X

ME

Montenegro

X

X (5)

X

X

X (14)

P

X

X

X

MG

Madagascar

X

P

O

O

X

MK

North Macedonia

X

X

X

X

X (14)

P

X

X

X

X

MM

Myanmar

X

P

O

O

X

MN

Mongolia

X

MU

Mauritius

X (14)

P

O

O

Δ

MX

Mexico

Δ

X

P

O

X

X

MY

Malaysia

Δ

X

P

O

O

MZ

Mozambique

X (15)

P

O

O

NA

Namibia

X

X (5)

P

X

NC

New Caledonia

X (15)

P

O

O

X

X

NG

Nigeria

X (15)

P

O

O

NI

Nicaragua

X (15)

P

O

O

X

NZ

New Zealand

X

X

O

X

O

X (14)

M

X

O

O

X

X

X

X

PA

Panama

X

P

O

O

PE

Peru

X

M

O

O

PH

Philippines

X

P

O

O

PK

Pakistan

X

PM

Saint Pierre and Miquelon

X

P

PN

Pitcairn Islands

X

PY

Paraguay

X

P

X

RS

Serbia

X

X

X

X (8)

X

X (14)

P

X

X

X

X

X

X

RU

Russia

X

X

X

X

O

P

X

X

X (9)

X

X

RW

Rwanda

SA

Saudi Arabia

X

P

O

O

SG

Singapore

Δ

Δ

Δ

X (10)

Δ

X (14)

P

Δ

Δ

X (10)

X (10)

SM

San Marino

X

Δ

O

P

X

O

X

SV

El Salvador

X

SY

Syria

SZ

Eswatini

X

P

TG

Togo

X

TH

Thailand

O

O

X

X

M

Δ

Δ

X

TN

Tunisia

X (14)

M

O

O

X

TR

Türkiye

X

X (14)

M

X

X

X

X

TW

Taiwan

X

P

O

X

X

TZ

Tanzania

X (15)

P

O

O

X

UA

Ukraine

X

X

X

X (14)

M

X

X

X

X

X

UG

Uganda

X

US

United States

X

X (11)

X

X

X

M

X

X

X

X

X

X

X

UY

Uruguay

X

X

X

X (14)

M

X

O

X

X

X

UZ

Uzbekistan

X

VE

Venezuela

X (15)

P

O

O

VN

Vietnam

X

M

O

O

X

WF

Wallis and Futuna

X

XK

Kosovo (12)

Δ

ZA

South Africa

P

X

X (13)

ZM

Zambia

X

---

(1)  List of third countries and territories (not limited to third countries recognised by the Union).

1

(2)  Camel milk only.

2

(3)  Only the region of Ras al Khaimah.

3

(4)  Hereinafter understood as the State of Israel, excluding the territories under the administration of the State of Israel after 5 June 1967, namely the Golan Heights, the Gaza Strip, East Jerusalem and the rest of the West Bank.

4

(5)  Ovine species only.

5

(6)  In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex, references to the United Kingdom do not include Northern Ireland.

6

(7)  In accordance with the Agreement of 21 June 1999 between the European Community and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132).

7

(8)  Export to the Union of live equidae intended for slaughter (food-producing animals only).

8

(9)  Reindeer only.

9

(10)  Only for consignments of fresh meat originating from New Zealand, destined to the Union and being unloaded, with or without storage, in Singapore and being reloaded in an approved establishment during transit through Singapore.

10

(11)  Caprine species only.

11

(12)  This designation is without prejudice to positions on status and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.

12

(13)  Ratites only.

13

(14)  Finfish only.

14

(15)  Crustaceans only.

15

(16)  Roes and caviar only.

16

(17)  Aquaculture covers finfish, including eels, and products of finfish (such as roes and caviar), and crustaceans. The third countries or regions thereof listed for live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods in Annex VIII are marked with an “M” in this column.

17

---

ANNEX II

Annex IV to Implementing Regulation (EU) 2021/405 is replaced by the following:

‘ANNEX IV

List of third countries authorized for the entry into the Union of consignments of eggs intended for placing on the market as Class A eggs as referred to in the second paragraph of Article 7

| COUNTRY ISO CODE | THIRD COUNTRY | REMARKS |
| --- | --- | --- |
| CH | Switzerland (1) | |
| GB | United Kingdom (2) | |
| JP | Japan | |
| MD | Moldova | |
| MK | North Macedonia | |
| UA | Ukraine | |

COUNTRY ISO CODE

THIRD COUNTRY

REMARKS

CH

Switzerland (1)

GB

United Kingdom (2)

JP

Japan

MD

Moldova

MK

North Macedonia

UA

Ukraine

---

(1)  In accordance with the Agreement of 21 June 1999 between the European Community and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132).

1

(2)  In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex references to the United Kingdom do not include Northern Ireland.’

2

---

| 9.3.2023 | EN | Official Journal of the European Union | L 71/22 |
| --- | --- | --- | --- |

9.3.2023

EN

Official Journal of the European Union

L 71/22

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/515

of 8 March 2023

renewing the approval of the active substance abamectin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) thereof,

Whereas:

| (1) | Commission Directive 2008/107/EC (2) included abamectin as an active substance in Annex I to Council Directive 91/414/EEC (3). |
| --- | --- |

(1)

Commission Directive 2008/107/EC (2) included abamectin as an active substance in Annex I to Council Directive 91/414/EEC (3).

| (2) | Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4). |
| --- | --- |

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

| (3) | The approval of the active substance abamectin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2023. |
| --- | --- |

(3)

The approval of the active substance abamectin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2023.

| (4) | An application for the renewal of the approval of the active substance abamectin was submitted to Austria, the rapporteur Member State, and Malta, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article. |
| --- | --- |

(4)

An application for the renewal of the approval of the active substance abamectin was submitted to Austria, the rapporteur Member State, and Malta, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

| (5) | The applicant submitted the supplementary dossiers to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State. |
| --- | --- |

(5)

The applicant submitted the supplementary dossiers to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

| (6) | The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 17 April 2019. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of abamectin. |
| --- | --- |

(6)

The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 17 April 2019. In its draft renewal assessment report, the rapporteur Member State proposed to renew the approval of abamectin.

| (7) | The Authority communicated the draft renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public. |
| --- | --- |

(7)

The Authority communicated the draft renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

| (8) | On 15 July 2020, the Authority communicated to the Commission its conclusion (6) on whether abamectin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority identified a number of issues that could not be finalised. In particular it identified risks as regards birds and mammals, aquatic organisms and soil macroorganisms. |
| --- | --- |

(8)

On 15 July 2020, the Authority communicated to the Commission its conclusion (6) on whether abamectin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority identified a number of issues that could not be finalised. In particular it identified risks as regards birds and mammals, aquatic organisms and soil macroorganisms.

| (9) | On 1 February 2022, the Commission sent a mandate to the Authority with a request to review the exposure and risk assessments as regards birds and mammals, aquatic organisms and soil macroorganisms. The Authority sent to the Commission an updated conclusion on 27 July 2022 (7). In its updated Conclusion, the Authority confirmed the risks identified in the previous assessment. |
| --- | --- |

(9)

On 1 February 2022, the Commission sent a mandate to the Authority with a request to review the exposure and risk assessments as regards birds and mammals, aquatic organisms and soil macroorganisms. The Authority sent to the Commission an updated conclusion on 27 July 2022 (7). In its updated Conclusion, the Authority confirmed the risks identified in the previous assessment.

| (10) | The Commission presented a renewal report and the draft Regulation for abamectin to the Standing Committee on Plants, Animals, Food and Feed, on 25 March 2021 and revised versions of the two documents on 8 December 2022 to take into account the outcomes in the updated Conclusion of the Authority. |
| --- | --- |

(10)

The Commission presented a renewal report and the draft Regulation for abamectin to the Standing Committee on Plants, Animals, Food and Feed, on 25 March 2021 and revised versions of the two documents on 8 December 2022 to take into account the outcomes in the updated Conclusion of the Authority.

| (11) | The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments on both versions of the renewal report, which have been carefully examined. |
| --- | --- |

(11)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments on both versions of the renewal report, which have been carefully examined.

| (12) | It has been established with respect to one or more representative uses of at least one plant protection product containing abamectin that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. |
| --- | --- |

(12)

It has been established with respect to one or more representative uses of at least one plant protection product containing abamectin that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

| (13) | The risk assessment for the renewal of the approval of the active substance abamectin is based on representative uses as insecticide and acaricide in protected crops. While it is not necessary, in the light of this risk assessment, to maintain the restriction to use only as insecticide and acaricide, it is necessary to provide, in accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, for certain conditions and restrictions. It is, in particular, appropriate to restrict the use of plant protection products containing abamectin to uses which allow controlled exchange of material and energy with the surroundings, so as to prevent the release of plant protection products into the environment and mitigate the high risk identified to aquatic organisms and wild terrestrial non-target organisms. Accordingly, uses in permanent greenhouses may be authorised. |
| --- | --- |

(13)

The risk assessment for the renewal of the approval of the active substance abamectin is based on representative uses as insecticide and acaricide in protected crops. While it is not necessary, in the light of this risk assessment, to maintain the restriction to use only as insecticide and acaricide, it is necessary to provide, in accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, for certain conditions and restrictions. It is, in particular, appropriate to restrict the use of plant protection products containing abamectin to uses which allow controlled exchange of material and energy with the surroundings, so as to prevent the release of plant protection products into the environment and mitigate the high risk identified to aquatic organisms and wild terrestrial non-target organisms. Accordingly, uses in permanent greenhouses may be authorised.

| (14) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(14)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (15) | Commission Implementing Regulation (EU) 2022/378 (8) extended the approval period of abamectin to 30 April 2023 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. Given that a decision on renewal has been taken ahead of that extended expiry date, and taking into account that the current approval of abamectin expires on 30 April 2023, this Regulation should enter into force as soon as possible and apply earlier then that date. |
| --- | --- |

(15)

Commission Implementing Regulation (EU) 2022/378 (8) extended the approval period of abamectin to 30 April 2023 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. Given that a decision on renewal has been taken ahead of that extended expiry date, and taking into account that the current approval of abamectin expires on 30 April 2023, this Regulation should enter into force as soon as possible and apply earlier then that date.

| (16) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(16)

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

Renewal of the approval of the active substance

The approval of the active substance abamectin, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

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

Article 3

Entry into force and date of application

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

Official Journal of the European Union

It shall apply from 1 April 2023.

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

Done at Brussels, 8 March 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  Commission Directive 2008/107/EC of 25 November 2008 amending Council Directive 91/414/EEC to include abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim as active substances (OJ L 316, 26.11.2008, p. 4).

2

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

3

(4)  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).

4

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

5

(6)  
  EFSA Journal 2020;18(8):6227. Available online: www.efsa.europa.eu.

6

EFSA Journal 2020

(7)  
  EFSA Journal 2022;20(8):7544. Available online: www.efsa.europa.eu.

7

EFSA Journal

(8)  Commission Implementing Regulation (EU) 2022/378 of 4 March 2022 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, malathion, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Trichoderma asperellum (formerly T. harzianum) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly T. harzianum) strain T11, Trichoderma gamsii (formerly T. viride) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram (OJ L 72, 7.3.2022, p. 2).

8

Bacillus subtilis

Bacillus thuringiensis

Bacillus thuringiensis

Bacillus thuringiensis

Beauveria bassiana

Cydia pomonella

Pseudomonas chlororaphis

Pythium oligandrum

Trichoderma asperellum

T. harzianum

Trichoderma atroviride

T. harzianum

Trichoderma gamsii

T. viride

Trichoderma harzianum

---

ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Abamectin
  CAS No 71751-41-2
  Avermectin B1a
  CAS No 65195-55-3
  Avermectin B1b
  CAS No 65195-56-4
  Abamectin
  CIPAC No 495 | Avermectin B1a
  (10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside
  Avermectin B1b
  (10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside | ≥ 850 g/kg abamectin (sum of avermectin B1a and avermectin B1b), min. 800 g/kg avermectin B1a and max. 200 g/kg avermectin B1b | 1 April 2023 | 31 March 2038 | Only uses which allow controlled exchange of material and energy with the surroundings and prevent release of plant protection products into the environment may be authorised, in particular uses in permanent greenhouses.
  For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Abamectin, and in particular Appendices I and II thereto, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  — | the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, such as the the use of gloves; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Abamectin

CAS No 71751-41-2

Avermectin B1a

CAS No 65195-55-3

Avermectin B1b

CAS No 65195-56-4

Abamectin

CIPAC No 495

Avermectin B1a

(10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside

Avermectin B1b

(10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside

≥ 850 g/kg abamectin (sum of avermectin B1a and avermectin B1b), min. 800 g/kg avermectin B1a and max. 200 g/kg avermectin B1b

1 April 2023

31 March 2038

Only uses which allow controlled exchange of material and energy with the surroundings and prevent release of plant protection products into the environment may be authorised, in particular uses in permanent greenhouses.

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Abamectin, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, such as the the use of gloves;

| — | the effect of photolysis on the levels of pesticide residues in crops. Particular attention is required to ensure that available residue trials on crops reflect the most critical residue situation. Where appropriate, depending on the zone, seasonal restrictions for the timing of application shall be applied (cf. representative uses excluded application from November till February). |
| --- | --- |

—

the effect of photolysis on the levels of pesticide residues in crops. Particular attention is required to ensure that available residue trials on crops reflect the most critical residue situation. Where appropriate, depending on the zone, seasonal restrictions for the timing of application shall be applied (cf. representative uses excluded application from November till February).

---

(1)  Further details on the identity and the specification of the active substance are provided in the renewal report.

---

ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

| (1) | in Part A, entry 210 on Abamectin is deleted; |
| --- | --- |

(1)

in Part A, entry 210 on Abamectin is deleted;

| (2) | in Part B, the following entry is added:











  No. | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‘157 | Abamectin
  CAS No 71751-41-2
  Avermectin B1a
  CAS No 65195-55-3
  Avermectin B1b
  CAS No 65195-56-4
  Abamectin
  CIPAC No 495 | Avermectin B1a
  (10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside
  Avermectin B1b
  (10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside | ≥ 850 g/kg abamectin (sum of avermectin B1a and avermectin B1b), min. 800 g/kg avermectin B1a and max. 200 g/kg avermectin B1b | 1 April 2023 | 31 March 2038 | Only uses which allow controlled exchange of material and energy with the surroundings and prevent release of plant protection products into the environment may be authorised, in particular uses in permanent greenhouses.
  For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Abamectin, and in particular Appendices I and II thereto, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  — | the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, such as the the use of gloves; |

(2)

in Part B, the following entry is added:

No.

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘157

Abamectin

CAS No 71751-41-2

Avermectin B1a

CAS No 65195-55-3

Avermectin B1b

CAS No 65195-56-4

Abamectin

CIPAC No 495

Avermectin B1a

(10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside

Avermectin B1b

(10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside

≥ 850 g/kg abamectin (sum of avermectin B1a and avermectin B1b), min. 800 g/kg avermectin B1a and max. 200 g/kg avermectin B1b

1 April 2023

31 March 2038

Only uses which allow controlled exchange of material and energy with the surroundings and prevent release of plant protection products into the environment may be authorised, in particular uses in permanent greenhouses.

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Abamectin, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, such as the the use of gloves;

| — | The effect of photolysis on the levels of pesticide residues in crops. Particular attention is required to ensure that available residue trials on crops reflect the most critical residue situation. Where appropriate, depending on the zone, seasonal restrictions for the timing of application shall be applied (cf. representative uses excluded application from November till February).’ |
| --- | --- |

—

The effect of photolysis on the levels of pesticide residues in crops. Particular attention is required to ensure that available residue trials on crops reflect the most critical residue situation. Where appropriate, depending on the zone, seasonal restrictions for the timing of application shall be applied (cf. representative uses excluded application from November till February).’

---

(1)  Further details on the identity and the specification of the active substance are provided in the renewal report.

---

| 9.3.2023 | EN | Official Journal of the European Union | L 71/27 |
| --- | --- | --- | --- |

9.3.2023

EN

Official Journal of the European Union

L 71/27

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/516

of 8 March 2023

amending Implementing Regulation (EU) 2020/2236 as regards the model animal health certificate for the entry into the Union of consignments of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption

(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 238(3), points (a) and (c), thereof,

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) (2), and in particular Article 90 thereof,

Whereas:

| (1) | Commission Implementing Regulation (EU) 2020/2236 (3) sets out the model animal health certificates for the entry into the Union and movements within the Union of consignments of aquatic animals and of certain products of animal origin from aquatic animals. |
| --- | --- |

(1)

Commission Implementing Regulation (EU) 2020/2236 (3) sets out the model animal health certificates for the entry into the Union and movements within the Union of consignments of aquatic animals and of certain products of animal origin from aquatic animals.

| (2) | In particular, Annex II to Implementing Regulation (EU) 2020/2236 sets out the model animal health certificate for the entry into the Union of consignments of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption (model ‘AQUA-ENTRY-ESTAB/RELEASE/OTHER’). Article 166 of Commission Delegated Regulation (EU) 2020/692 (4) was recently amended by Delegated Regulation (EU) 2023/119 (5) in order to permit aquatic animal health professionals to perform clinical inspections on consignments of aquatic animals prior to export to the Union, provided they are authorised to do so under the law of the exporting third country or territory. Those new requirements for the entry into the Union of those consignments should be reflected in point II.3.2. of that model animal health certificate. Annex II to Implementing Regulation (EU) 2020/2236 should therefore be amended accordingly. |
| --- | --- |

(2)

In particular, Annex II to Implementing Regulation (EU) 2020/2236 sets out the model animal health certificate for the entry into the Union of consignments of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption (model ‘AQUA-ENTRY-ESTAB/RELEASE/OTHER’). Article 166 of Commission Delegated Regulation (EU) 2020/692 (4) was recently amended by Delegated Regulation (EU) 2023/119 (5) in order to permit aquatic animal health professionals to perform clinical inspections on consignments of aquatic animals prior to export to the Union, provided they are authorised to do so under the law of the exporting third country or territory. Those new requirements for the entry into the Union of those consignments should be reflected in point II.3.2. of that model animal health certificate. Annex II to Implementing Regulation (EU) 2020/2236 should therefore be amended accordingly.

| (3) | In order to avoid any disruption to trade as regards the entry into the Union of consignments of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption, the use of animal health certificate issued in accordance with Implementing Regulation (EU) 2020/2236, as applicable prior to the amendments made by this Implementing Regulation, should continue to be authorised during a transitional period subject to certain conditions. |
| --- | --- |

(3)

In order to avoid any disruption to trade as regards the entry into the Union of consignments of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption, the use of animal health certificate issued in accordance with Implementing Regulation (EU) 2020/2236, as applicable prior to the amendments made by this Implementing Regulation, should continue to be authorised during a transitional period subject to certain conditions.

| (4) | As Implementing Regulation (EU) 2020/2236 applies from 21 April 2021, in the interest of legal certainty and to facilitate trade, the amendments to be made to Implementing Regulation (EU) 2020/2236 by this Regulation should take effect as a matter of urgency. |
| --- | --- |

(4)

As Implementing Regulation (EU) 2020/2236 applies from 21 April 2021, in the interest of legal certainty and to facilitate trade, the amendments to be made to Implementing Regulation (EU) 2020/2236 by this Regulation should take effect as a matter of urgency.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(5)

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 Implementing Regulation (EU) 2020/2236 is amended in accordance with the Annex to this Regulation.

Article 2

For a transitional period until 15 December 2023, consignments of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption, accompanied by the animal health certificate issued in accordance with the model set out in Annex II to Implementing Regulation (EU) 2020/2236, as applicable before the amendments made to that Implementing Regulation by this Implementing Regulation, shall continue to be authorised for entry into the Union provided that the certificate was issued no later than 15 September 2023.

Article 3

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

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

Done at Brussels, 8 March 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 84, 31.3.2016, p. 1.

1

(2)  
  OJ L 95, 7.4.2017, p. 1.

2

(3)  Commission Implementing Regulation (EU) 2020/2236 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates for the entry into the Union and movements within the Union of consignments of aquatic animals and of certain products of animal origin from aquatic animals, official certification regarding such certificates and repealing Regulation (EC) No 1251/2008 (OJ L 442, 30.12.2020, p. 410).

3

(4)  Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379).

4

(5)  Commission Delegated Regulation (EU) 2023/119 of 9 November 2022 amending Delegated Regulation (EU) 2020/692 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 16, 18.1.2023, p. 5).

5

---

ANNEX

Annex II to Implementing Regulation (EU) 2020/2236 is replaced by the following:

‘ANNEX II

Annex II contains the following model animal health certificate:

Model

| AQUA-ENTRY-ESTAB/RELEASE/OTHER | Model animal health certificate for the entry into the Union of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption |
| --- | --- |

AQUA-ENTRY-ESTAB/RELEASE/OTHER

Model animal health certificate for the entry into the Union of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption

MODEL ANIMAL HEALTH CERTIFICATE FOR THE ENTRY INTO THE UNION OF AQUATIC ANIMALS INTENDED FOR CERTAIN AQUACULTURE ESTABLISHMENTS, FOR RELEASE INTO THE WILD OR FOR OTHER PURPOSES, EXCLUDING DIRECT HUMAN CONSUMPTION (MODEL ‘AQUA-ENTRY-ESTAB/RELEASE/OTHER’)

Image 1

Image 2

Image 3

Image 4

Image 5

Image 6

Image 7

---

Corrigenda

| 9.3.2023 | EN | Official Journal of the European Union | L 71/37 |
| --- | --- | --- | --- |

9.3.2023

EN

Official Journal of the European Union

L 71/37

---

Corrigendum to Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices

(
  Official Journal of the European Union L 20 of 31 January 2022
  )

| 1. | On page 11, Article 1, point (a): |
| --- | --- |

1.

On page 11, Article 1, point (a):

for:

| ‘(a) | preparing for, preventing, coordinating and managing the impact of public health emergencies on medicinal products and on medical devices and the impact of major events on medicinal products and on medical devices at Union level;’, |
| --- | --- |

‘(a)

preparing for, preventing, coordinating and managing the impact of public health emergencies on medicinal products and on medical devices and the impact of major events on medicinal products and on medical devices at Union level;’,

read:

| ‘(a) | preparing for, preventing, coordinating and managing the impact of public health emergencies on medicinal products and on medical devices and the impact of major events on medicinal products at Union level;’. |
| --- | --- |

‘(a)

preparing for, preventing, coordinating and managing the impact of public health emergencies on medicinal products and on medical devices and the impact of major events on medicinal products at Union level;’.

| 2. | On page 14, Article 4(2): |
| --- | --- |

2.

On page 14, Article 4(2):

for:

‘2.   To facilitate the monitoring referred to in paragraph 1, the national competent authorities for medicinal products, acting through the single points of contact referred to in Article 3(6), or the platform referred to in Article 13 (the ‘ESMP’), once it is fully functional, shall report in a timely manner to the Agency [...].’,

read:

‘2.   To facilitate the monitoring referred to in paragraph 1, the national competent authorities for medicinal products, acting through the single points of contact referred to in Article 3(6), second subparagraph, or the platform referred to in Article 13 (the ‘ESMP’), once it is fully functional, shall report in a timely manner to the Agency [...].’.

| 3. | On page 16, Article 8(1): |
| --- | --- |

3.

On page 16, Article 8(1):

for:

‘1.   For the duration of a public health emergency, or following the recognition of a major event as referred to in Article 4(3) until it has been confirmed that the major event has been sufficiently addressed pursuant to Article 4(4), the MSSG shall regularly report the results of the monitoring referred to in Article 7 to the Commission and the single points of contact referred to in Article 3(6), and, in particular, shall signal any actual or potential shortages of medicinal products included on the critical medicines lists or any event that is likely to lead to a major event.’,

read:

‘1.   For the duration of a public health emergency, or following the recognition of a major event as referred to in Article 4(3) until it has been confirmed that the major event has been sufficiently addressed pursuant to Article 4(4), the MSSG shall regularly report the results of the monitoring referred to in Article 7 to the Commission and the single points of contact referred to in Article 3(6), second subparagraph, and, in particular, shall signal any actual or potential shortages of medicinal products included on the critical medicines lists or any event that is likely to lead to a major event.’.

| 4. | On page 16, Article 8(2): |
| --- | --- |

4.

On page 16, Article 8(2):

for:

‘2.   Where requested by the Commission or one or more single point of contact as referred to in Article 3(6), the MSSG shall provide aggregated data and demand forecasts to support its findings and conclusions. In that regard, the MSSG shall: [...]’,

read:

‘2.   Where requested by the Commission or one or more single point of contact as referred to in Article 3(6), second subparagraph, the MSSG shall provide aggregated data and demand forecasts to support its findings and conclusions. In that regard, the MSSG shall: [...]’.

| 5. | On page 18, Article 9(2), point (d): |
| --- | --- |

5.

On page 18, Article 9(2), point (d):

for:

| ‘(d) | request information on medicinal products on the critical medicines lists from the single points of contact referred to in Article 3(6) on the basis of the set of information referred to in Article 6(4), and set a deadline for the submission of that information, if that information is not available in the ESMP.’, |
| --- | --- |

‘(d)

request information on medicinal products on the critical medicines lists from the single points of contact referred to in Article 3(6) on the basis of the set of information referred to in Article 6(4), and set a deadline for the submission of that information, if that information is not available in the ESMP.’,

read:

| ‘(d) | request information on medicinal products on the critical medicines lists from the single points of contact referred to in Article 3(6), second subparagraph, on the basis of the set of information referred to in Article 6(4), and set a deadline for the submission of that information, if that information is not available in the ESMP.’. |
| --- | --- |

‘(d)

request information on medicinal products on the critical medicines lists from the single points of contact referred to in Article 3(6), second subparagraph, on the basis of the set of information referred to in Article 6(4), and set a deadline for the submission of that information, if that information is not available in the ESMP.’.

| 6. | On page 18, Article 10(2), second subparagraph: |
| --- | --- |

6.

On page 18, Article 10(2), second subparagraph:

for:

‘The marketing authorisation holders referred to in the first subparagraph of this paragraph shall submit the requested information by the deadline set by the Agency, through the single points of contact referred to in Article 9(2), point (b), using the monitoring and reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively. Those marketing authorisation holders shall provide updates where necessary.’,

read:

‘The marketing authorisation holders referred to in the first subparagraph of this paragraph shall submit the requested information by the deadline set by the Agency, through the single points of contact referred to in Article 9(2), point (a), using the monitoring and reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively. Those marketing authorisation holders shall provide updates where necessary.’.

| 7. | On page 19, Article 11(1), point (a): |
| --- | --- |

7.

On page 19, Article 11(1), point (a):

for:

| ‘(a) | submit the set of information referred to in Article 6(4) including available and estimated data on volume of demand and demand forecasts, through the single point of contact referred to in Article 3(6) and using the reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively;’, |
| --- | --- |

‘(a)

submit the set of information referred to in Article 6(4) including available and estimated data on volume of demand and demand forecasts, through the single point of contact referred to in Article 3(6) and using the reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively;’,

read:

| ‘(a) | submit the set of information referred to in Article 9(2), point (d), including available and estimated data on volume of demand and demand forecasts, through the single point of contact referred to in Article 3(6), second subparagraph, using the reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively;’. |
| --- | --- |

‘(a)

submit the set of information referred to in Article 9(2), point (d), including available and estimated data on volume of demand and demand forecasts, through the single point of contact referred to in Article 3(6), second subparagraph, using the reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively;’.

| 8. | On page 20, Article 11(3): |
| --- | --- |

8.

On page 20, Article 11(3):

for:

‘3.   Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article on volumes of sales of and volumes of prescriptions for medicinal products which provides evidence of an actual or potential shortage of a medicinal product included on the critical medicines lists, including data referred to in Article 23a, third paragraph, of Directive 2001/83/EC, they shall immediately provide such information to the MSSG through their respective single points of contact referred to in Article 3(6) of this Regulation.’,

read:

‘3.   Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article on volumes of sales of and volumes of prescriptions for medicinal products which provides evidence of an actual or potential shortage of a medicinal product included on the critical medicines lists, including data referred to in Article 23a, third paragraph, of Directive 2001/83/EC, they shall immediately provide such information to the MSSG through their respective single points of contact referred to in Article 3(6), second subparagraph, of this Regulation.’.

| 9. | On page 21, Article 13(3), point (b): |
| --- | --- |

9.

On page 21, Article 13(3), point (b):

for:

| ‘(b) | Member States shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 9(1), point (d), in accordance with Articles 9 and 11.’, |
| --- | --- |

‘(b)

Member States shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 9(1), point (d), in accordance with Articles 9 and 11.’,

read:

| ‘(b) | Member States shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 3(6), second subparagraph, in accordance with Articles 9 and 11.’. |
| --- | --- |

‘(b)

Member States shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 3(6), second subparagraph, in accordance with Articles 9 and 11.’.

| 10. | On page 21, Article 13(4), point (b): |
| --- | --- |

10.

On page 21, Article 13(4), point (b):

for:

| ‘(b) | Member States shall use the ESMP to report to the Agency on shortages of medicinal products that are likely to lead to a public health emergency or major event in accordance with Article 4(2), through the single points of contact referred to in Article 9(1), point (e).’, |
| --- | --- |

‘(b)

Member States shall use the ESMP to report to the Agency on shortages of medicinal products that are likely to lead to a public health emergency or major event in accordance with Article 4(2), through the single points of contact referred to in Article 9(1), point (e).’,

read:

| ‘(b) | Member States shall use the ESMP to report to the Agency on shortages of medicinal products that are likely to lead to a public health emergency or major event in accordance with Article 4(2), through the single points of contact referred to in Article 3(6), second subparagraph.’. |
| --- | --- |

‘(b)

Member States shall use the ESMP to report to the Agency on shortages of medicinal products that are likely to lead to a public health emergency or major event in accordance with Article 4(2), through the single points of contact referred to in Article 3(6), second subparagraph.’.

| 11. | On page 28, Article 22(2): |
| --- | --- |

11.

On page 28, Article 22(2):

for:

‘2.   For the purposes of Article 25(2), the MDSSG shall adopt and make publicly available the set of information referred to in Article 25(2), points (b) and (c), that is necessary to monitor the supply of and demand for medical devices included on the public health emergency critical devices list, and inform the working party referred to in Article 21(5) of that set of information.’,

read:

‘2.   For the purposes of Article 25(2), the MDSSG shall adopt and make publicly available the set of information referred to in Article 25(2), points (c) and (d), that is necessary to monitor the supply of and demand for medical devices included on the public health emergency critical devices list, and inform the working party referred to in Article 21(5) of that set of information.’.

| 12. | On page 28, Article 24(1): |
| --- | --- |

12.

On page 28, Article 24(1):

for:

‘1.   For the duration of the public health emergency, the MDSSG shall regularly report the results of the monitoring referred to in Article 23 to the Commission and the single points of contact referred to in Article 25(2), point (a), and, in particular, shall signal any actual or potential shortages of medical devices included on the public health emergency critical devices list.’,

read:

‘1.   For the duration of the public health emergency, the MDSSG shall regularly report the results of the monitoring referred to in Article 23 to the Commission and the single points of contact referred to in Article 21(5), second subparagraph, and, in particular, shall signal any actual or potential shortages of medical devices included on the public health emergency critical devices list.’.

| 13. | On page 29, Article 24(5): |
| --- | --- |

13.

On page 29, Article 24(5):

for:

‘5.   Where requested by the Commission, the MDSSG may coordinate measures taken by the national competent authorities for medical devices, manufacturers of medical devices, notified bodies, and other entities, as relevant, to prevent or mitigate actual or potential shortages of medical devices in the context of a public health emergency or major event.’,

read:

‘5.   Where requested by the Commission, the MDSSG may coordinate measures taken by the national competent authorities for medical devices, manufacturers of medical devices, notified bodies, and other entities, as relevant, to prevent or mitigate actual or potential shortages of medical devices in the context of a public health emergency.’.

| 14. | On page 31, Article 27(1), point (a): |
| --- | --- |

14.

On page 31, Article 27(1), point (a):

for:

| ‘(a) | submit the set of information referred to in Article 22(2), including available information about needs related to the medical devices included in the public health emergency critical devices list, and available and estimated data on volume of demand and demand forecasts for those medical devices, through the respective single point of contact referred to in Article 25(2), point (a), and using the monitoring and reporting methods and systems established pursuant to Article 25(1), point (b);’, |
| --- | --- |

‘(a)

submit the set of information referred to in Article 22(2), including available information about needs related to the medical devices included in the public health emergency critical devices list, and available and estimated data on volume of demand and demand forecasts for those medical devices, through the respective single point of contact referred to in Article 25(2), point (a), and using the monitoring and reporting methods and systems established pursuant to Article 25(1), point (b);’,

read:

| ‘(a) | submit the set of information referred to in Article 25(2), point (d), including available information about needs related to the medical devices included in the public health emergency critical devices list, and available and estimated data on volume of demand and demand forecasts for those medical devices, through the respective single point of contact referred to in Article 21(5), second subparagraph, using the monitoring and reporting methods and systems established pursuant to Article 25(1), point (b);’. |
| --- | --- |

‘(a)

submit the set of information referred to in Article 25(2), point (d), including available information about needs related to the medical devices included in the public health emergency critical devices list, and available and estimated data on volume of demand and demand forecasts for those medical devices, through the respective single point of contact referred to in Article 21(5), second subparagraph, using the monitoring and reporting methods and systems established pursuant to Article 25(1), point (b);’.

| 15. | On page 32, Article 27(3): |
| --- | --- |

15.

On page 32, Article 27(3):

for:

‘3.   Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article, which provides evidence of an actual or potential shortage of medical devices, they shall immediately provide such information to the MDSSG through their respective single point of contact referred to in Article 25(2), point (a).’,

read:

‘3.   Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article, which provides evidence of an actual or potential shortage of medical devices, they shall immediately provide such information to the MDSSG through their respective single point of contact referred to in Article 21(5), second subparagraph.’.

| 16. | On page 32, Article 27(4), point (b): |
| --- | --- |

16.

On page 32, Article 27(4), point (b):

for:

| ‘(b) | take into account any recommendations referred to in Article 24(3) and any guidelines referred to in Article 28, point (b), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 12, point (a);’, |
| --- | --- |

‘(b)

take into account any recommendations referred to in Article 24(3) and any guidelines referred to in Article 28, point (b), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 12, point (a);’,

read:

| ‘(b) | take into account any recommendations referred to in Article 24(3) and any guidelines referred to in Article 28, point (b), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 28, point (a);’. |
| --- | --- |

‘(b)

take into account any recommendations referred to in Article 24(3) and any guidelines referred to in Article 28, point (b), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 28, point (a);’.

---

| 9.3.2023 | EN | Official Journal of the European Union | L 71/42 |
| --- | --- | --- | --- |

9.3.2023

EN

Official Journal of the European Union

L 71/42

---

Corrigendum to Council Implementing Regulation (EU) 2023/419 of 24 February 2023 implementing Article 8a of Regulation (EC) No 765/2006 concerning restrictive measures in view of the situation in Belarus and the involvement of Belarus in the Russian aggression against Ukraine

(
  Official Journal of the European Union L 61 of 27 February 2023
  )

On page 22, in the Annex, in the introductory wording:

for:

‘Annex I to Regulation (EC) No 765/2006 is amended as follows:

| (1) | in Table “A. Natural persons referred to in Article 2(1)”, entries 10, 17, 20, 22, 35, 39, 41, 42, 64, 65, 71, 73, 75, 78, 85, 87, 89, 90, 123, 125 and 179 are replaced by the following:’, |
| --- | --- |

(1)

in Table “A. Natural persons referred to in Article 2(1)”, entries 10, 17, 20, 22, 35, 39, 41, 42, 64, 65, 71, 73, 75, 78, 85, 87, 89, 90, 123, 125 and 179 are replaced by the following:’,

read:

‘Annex I to Regulation (EC) No 765/2006 is amended as follows:

| (1) | in Table “A. Natural persons referred to in Article 2(1)”, entries 10, 17, 20, 22, 35, 39, 41, 42, 64, 65, 71, 73, 75, 78, 85, 87, 89, 90, 104, 123, 125, 129, 131, 179 and 195 are replaced by the following:’. |
| --- | --- |

(1)

in Table “A. Natural persons referred to in Article 2(1)”, entries 10, 17, 20, 22, 35, 39, 41, 42, 64, 65, 71, 73, 75, 78, 85, 87, 89, 90, 104, 123, 125, 129, 131, 179 and 195 are replaced by the following:’.

---

| 9.3.2023 | EN | Official Journal of the European Union | L 71/43 |
| --- | --- | --- | --- |

9.3.2023

EN

Official Journal of the European Union

L 71/43

---

Corrigendum to Commission Regulation (EU) 2023/466 of 3 March 2023 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, novaluron and tetraconazole in or on certain products

(
  Official Journal of the European Union L 68 of 6 March 2023
  )

On page 78, in the Annex, point (3), in the header of column (3) of the table:

for:

‘(sum of constituent isomers) (F)’,

read:

‘Novaluron (sum of constituent isomers) (F)’.

---