# Official Journal L 91/2021

| | ISSN 1977-0677 |
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| Official Journal
  of the European Union | L 91 |
| | |
| English edition | Legislation | Volume 6417 March 2021 |

ISSN 1977-0677

Official Journal

of the European Union

L 91

English edition

Legislation

Volume 6417 March 2021

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2021/457 of 13 January 2021 amending Delegated Regulation (EU) 2016/161 as regards a derogation from the obligation of wholesalers to decommission the unique identifier of products exported to the United Kingdom (
  1
  ) | 1 |
| | * | Commission Implementing Regulation (EU) 2021/458 of 10 March 2021 approving non-minor amendments to the product specification for a name entered in the register of protected designations of origin and protected geographical indications Πατάτα Νάξου (Patata Naxou) (PGI) | 3 |
| | * | Commission Implementing Regulation (EU) 2021/459 of 16 March 2021 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance fenpyrazamine (
  1
  ) | 4 |
| | * | Commission Implementing Regulation (EU) 2021/460 of 16 March 2021 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for Ukraine in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into and transit through the Union in relation to highly pathogenic avian influenza (
  1
  ) | 7 |
| | * | Commission Implementing Regulation (EU) 2021/461 of 16 March 2021 amending Regulation (EC) No 1235/2008 as regards the date for receiving requests for the recognition of control authorities and control bodies for the purpose of equivalence under the arrangements for imports of organic products based on Council Regulation (EC) No 834/2007 (
  1
  ) | 14 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Delegated Regulation (EU) 2021/457 of 13 January 2021 amending Delegated Regulation (EU) 2016/161 as regards a derogation from the obligation of wholesalers to decommission the unique identifier of products exported to the United Kingdom (
  1
  )

1

1

*

Commission Implementing Regulation (EU) 2021/458 of 10 March 2021 approving non-minor amendments to the product specification for a name entered in the register of protected designations of origin and protected geographical indications Πατάτα Νάξου (Patata Naxou) (PGI)

3

*

Commission Implementing Regulation (EU) 2021/459 of 16 March 2021 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance fenpyrazamine (
  1
  )

1

4

*

Commission Implementing Regulation (EU) 2021/460 of 16 March 2021 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for Ukraine in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into and transit through the Union in relation to highly pathogenic avian influenza (
  1
  )

1

7

*

Commission Implementing Regulation (EU) 2021/461 of 16 March 2021 amending Regulation (EC) No 1235/2008 as regards the date for receiving requests for the recognition of control authorities and control bodies for the purpose of equivalence under the arrangements for imports of organic products based on Council Regulation (EC) No 834/2007 (
  1
  )

1

14

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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

| 17.3.2021 | EN | Official Journal of the European Union | L 91/1 |
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17.3.2021

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Official Journal of the European Union

L 91/1

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COMMISSION DELEGATED REGULATION (EU) 2021/457

of 13 January 2021

amending Delegated Regulation (EU) 2016/161 as regards a derogation from the obligation of wholesalers to decommission the unique identifier of products exported to the United Kingdom

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (1), and in particular Article 54a(2)(d) thereof,

Whereas:

| (1) | Article 54a(1) of Directive 2001/83/EC provides that medical products subject to prescription shall bear safety features. |
| --- | --- |

(1)

Article 54a(1) of Directive 2001/83/EC provides that medical products subject to prescription shall bear safety features.

| (2) | Pursuant to Article 22(a) of Commission Delegated Regulation (EU) 2016/161 (2), a wholesaler is to decommission the unique identifier of medicinal products which he intends to distribute outside of the Union. |
| --- | --- |

(2)

Pursuant to Article 22(a) of Commission Delegated Regulation (EU) 2016/161 (2), a wholesaler is to decommission the unique identifier of medicinal products which he intends to distribute outside of the Union.

| (3) | On 1 February 2020, the United Kingdom withdrew from the European Union and from the European Atomic Energy Community. Pursuant to Articles 126 and 127 of 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 (the ‘Withdrawal Agreement’), Union law is applicable to and in the United Kingdom during a transition period that is to end on 31 December 2020 (‘transition period’). |
| --- | --- |

(3)

On 1 February 2020, the United Kingdom withdrew from the European Union and from the European Atomic Energy Community. Pursuant to Articles 126 and 127 of 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 (the ‘Withdrawal Agreement’), Union law is applicable to and in the United Kingdom during a transition period that is to end on 31 December 2020 (‘transition period’).

| (4) | In accordance with Article 185 of the Withdrawal Agreement and Article 5(4) of the Protocol on Ireland/Northern Ireland, Union legislation on medicinal products apply in Northern Ireland after the end of the transition period. |
| --- | --- |

(4)

In accordance with Article 185 of the Withdrawal Agreement and Article 5(4) of the Protocol on Ireland/Northern Ireland, Union legislation on medicinal products apply in Northern Ireland after the end of the transition period.

| (5) | The withdrawal of the United Kingdom from the Union would, in the absence of a derogation from the applicable rules, thus have the effect that the unique identifiers must be decommissioned for medicinal products intended to be distributed in the United Kingdom. |
| --- | --- |

(5)

The withdrawal of the United Kingdom from the Union would, in the absence of a derogation from the applicable rules, thus have the effect that the unique identifiers must be decommissioned for medicinal products intended to be distributed in the United Kingdom.

| (6) | A number of medicinal products are supplied to Cyprus, Ireland, Malta or Northern Ireland through Great Britain. After the end of the transition period, in accordance with Article 54a(1) of Directive 2001/83/EC, it would be for importers holding a manufacturing authorisation in those areas to affix a new unique identifier on the medicinal products when they are placed on the market. However, there are currently no importers holding a manufacturing authorisation in Cyprus, Ireland, Malta and Northern Ireland and therefore no importers in those areas that could meet that obligation from 1 January 2021. In order to ensure supplies in compliance with the obligation to affix a new unique identifier, the supply chains need to be redesigned. |
| --- | --- |

(6)

A number of medicinal products are supplied to Cyprus, Ireland, Malta or Northern Ireland through Great Britain. After the end of the transition period, in accordance with Article 54a(1) of Directive 2001/83/EC, it would be for importers holding a manufacturing authorisation in those areas to affix a new unique identifier on the medicinal products when they are placed on the market. However, there are currently no importers holding a manufacturing authorisation in Cyprus, Ireland, Malta and Northern Ireland and therefore no importers in those areas that could meet that obligation from 1 January 2021. In order to ensure supplies in compliance with the obligation to affix a new unique identifier, the supply chains need to be redesigned.

| (7) | In order to ensure that medicinal products are marketed with a unique identifier in the small markets currently dependent on the United Kingdom for their supplies of medicinal products, it is therefore necessary to grant a temporary derogation from the obligation of wholesalers to decommission the unique identifier of the products which they intend to distribute in the United Kingdom as those products may be re-exported to the Union. This derogation should not affect the application of Union law to and in the United Kingdom in respect of Northern Ireland in accordance with Article 5(4) of the Protocol on Ireland/Northern Ireland to the Withdrawal Agreement in conjunction with Annex 2 to that Protocol. |
| --- | --- |

(7)

In order to ensure that medicinal products are marketed with a unique identifier in the small markets currently dependent on the United Kingdom for their supplies of medicinal products, it is therefore necessary to grant a temporary derogation from the obligation of wholesalers to decommission the unique identifier of the products which they intend to distribute in the United Kingdom as those products may be re-exported to the Union. This derogation should not affect the application of Union law to and in the United Kingdom in respect of Northern Ireland in accordance with Article 5(4) of the Protocol on Ireland/Northern Ireland to the Withdrawal Agreement in conjunction with Annex 2 to that Protocol.

| (8) | Delegated Regulation (EU) 2016/161 should therefore be amended accordingly. |
| --- | --- |

(8)

Delegated Regulation (EU) 2016/161 should therefore be amended accordingly.

| (9) | Having regard to the imminent end of the transition period, this Regulation should enter into force as a matter of urgency. As the transition period of the withdrawal agreement ends on 31 December 2020, this Regulation should apply from 1 January 2021, |
| --- | --- |

(9)

Having regard to the imminent end of the transition period, this Regulation should enter into force as a matter of urgency. As the transition period of the withdrawal agreement ends on 31 December 2020, this Regulation should apply from 1 January 2021,

HAS ADOPTED THIS REGULATION:

Article 1

In Article 22 of Delegated Regulation (EU) 2016/161, the following paragraph is added:

‘By way of derogation from point (a), from 1 January 2021 to 31 December 2021 the obligation to decommission the unique identifier of medicinal products which the wholesaler intends to distribute outside of the Union shall not apply to products which he intends to distribute in the United Kingdom (*1).

Article 2

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

It shall apply from 1 January 2021.

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

Done at Brussels, 13 January 2021.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).

2

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| 17.3.2021 | EN | Official Journal of the European Union | L 91/3 |
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17.3.2021

EN

Official Journal of the European Union

L 91/3

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COMMISSION IMPLEMENTING REGULATION (EU) 2021/458

of 10 March 2021

approving non-minor amendments to the product specification for a name entered in the register of protected designations of origin and protected geographical indications ‘Πατάτα Νάξου’ (Patata Naxou) (PGI)

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Greece’s application for the approval of amendments to the specification for the protected geographical indication ‘Πατάτα Νάξου’ (Patata Naxou), registered under Commission Implementing Regulation (EU) No 1250/2011 (2). |
| --- | --- |

(1)

Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Greece’s application for the approval of amendments to the specification for the protected geographical indication ‘Πατάτα Νάξου’ (Patata Naxou), registered under Commission Implementing Regulation (EU) No 1250/2011 (2).

| (2) | Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation. |
| --- | --- |

(2)

Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

| (3) | As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved, |
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(3)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

HAS ADOPTED THIS REGULATION:

Article 1

The amendments to the product specification published in the Official Journal of the European Union regarding the name ‘Πατάτα Νάξου’ (Patata Naxou) (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, 10 March 2021.

For the Commission,

On behalf of the President,

Janusz WOJCIECHOWSKI

Member of the Commission

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

1

(2)  Commission Implementing Regulation (EU) No 1250/2011 of 29 November 2011 entering a name in the register of protected designations of origin and protected geographical indications (Πατάτα Νάξου (Patata Naxou) (PGI)) (OJ L 319, 2.12.2011, p. 41).

2

(3)  
  OJ C 383, 13.11.2020, p. 12.

3

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| 17.3.2021 | EN | Official Journal of the European Union | L 91/4 |
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17.3.2021

EN

Official Journal of the European Union

L 91/4

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COMMISSION IMPLEMENTING REGULATION (EU) 2021/459

of 16 March 2021

amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance fenpyrazamine

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | Commission Implementing Regulation (EU) No 595/2012 (2) approved fenpyrazamine as an active substance in accordance with Regulation (EC) No 1107/2009 subject to certain conditions, requiring, in particular, the examining Member State to inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
| --- | --- |

(1)

Commission Implementing Regulation (EU) No 595/2012 (2) approved fenpyrazamine as an active substance in accordance with Regulation (EC) No 1107/2009 subject to certain conditions, requiring, in particular, the examining Member State to inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

| (2) | In December 2013, the applicant submitted an updated dossier intended to provide the information on specification of the technical material as commercially manufactured to the rapporteur Member State Austria within the time period provided for its submission. The updated dossier was evaluated by the rapporteur Member State in the form of an Addendum to the Draft Assessment Report. |
| --- | --- |

(2)

In December 2013, the applicant submitted an updated dossier intended to provide the information on specification of the technical material as commercially manufactured to the rapporteur Member State Austria within the time period provided for its submission. The updated dossier was evaluated by the rapporteur Member State in the form of an Addendum to the Draft Assessment Report.

| (3) | On 23 April 2014, Austria distributed the addendum to the Member States, the applicant and the European Food Safety Authority (‘the Authority’) for comments, collated together with all comments in the format of a reporting table, which was submitted to the Authority on 7 July 2014. The Authority added its scientific views on the specific points raised during the commenting phase in the reporting table. |
| --- | --- |

(3)

On 23 April 2014, Austria distributed the addendum to the Member States, the applicant and the European Food Safety Authority (‘the Authority’) for comments, collated together with all comments in the format of a reporting table, which was submitted to the Authority on 7 July 2014. The Authority added its scientific views on the specific points raised during the commenting phase in the reporting table.

| (4) | On 13 August 2014, the Authority published a technical report (3) summarising the outcome of this consultation process for fenpyrazamine. |
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(4)

On 13 August 2014, the Authority published a technical report (3) summarising the outcome of this consultation process for fenpyrazamine.

| (5) | The draft assessment report, the addendum and the technical report were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 18 May 2020 in the format of the Commission review report for fenpyrazamine. |
| --- | --- |

(5)

The draft assessment report, the addendum and the technical report were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 18 May 2020 in the format of the Commission review report for fenpyrazamine.

| (6) | The Commission invited the applicant to submit its comments on the Commission review report for fenpyrazamine. |
| --- | --- |

(6)

The Commission invited the applicant to submit its comments on the Commission review report for fenpyrazamine.

| (7) | In its review report the Commission considered that the technical specification proposed in the approval of fenpyrazamine needs to be changed from pilot to commercial production. The impurity hydrazine, a starting material, has been identified during the assessment as a relevant impurity, since it was detected in the reanalysed pilot plant batches as well as in the commercial plant batches. Bearing in mind that the relevant impurity hydrazine is of toxicological concern, the Commission has concluded that a maximum content of this impurity in the technical material should not exceed 0,0001 % (1 mg/kg). |
| --- | --- |

(7)

In its review report the Commission considered that the technical specification proposed in the approval of fenpyrazamine needs to be changed from pilot to commercial production. The impurity hydrazine, a starting material, has been identified during the assessment as a relevant impurity, since it was detected in the reanalysed pilot plant batches as well as in the commercial plant batches. Bearing in mind that the relevant impurity hydrazine is of toxicological concern, the Commission has concluded that a maximum content of this impurity in the technical material should not exceed 0,0001 % (1 mg/kg).

| (8) | In order to ensure a high level of protection for consumers it is, therefore, appropriate to establish a maximum level for this impurity in the commercially manufactured active substance. |
| --- | --- |

(8)

In order to ensure a high level of protection for consumers it is, therefore, appropriate to establish a maximum level for this impurity in the commercially manufactured active substance.

| (9) | The Annex to Commission Implementing Regulation (EU) No 540/2011 (4) should therefore be amended accordingly. |
| --- | --- |

(9)

The Annex to Commission Implementing Regulation (EU) No 540/2011 (4) should therefore be amended accordingly.

| (10) | Member States should be allowed sufficient time to amend or withdraw authorisations for plant protection products containing fenpyrazamine, which are not complying with the specification of the technical material as commercially manufactured and the restricted conditions of approval. |
| --- | --- |

(10)

Member States should be allowed sufficient time to amend or withdraw authorisations for plant protection products containing fenpyrazamine, which are not complying with the specification of the technical material as commercially manufactured and the restricted conditions of approval.

| (11) | For plant protection products containing fenpyrazamine, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should expire, at the latest, 15 months after the entry into force of this Regulation. |
| --- | --- |

(11)

For plant protection products containing fenpyrazamine, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should expire, at the latest, 15 months after the entry into force of this Regulation.

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

(12)

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

HAS ADOPTED THIS REGULATION:

Article 1

Amendment to Implementing Regulation (EU) No 540/2011

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

Article 2

Transitional measures

Member States shall, where necessary, amend or withdraw existing authorisations for plant protection products containing fenpyrazamine as active substance by 6 July 2021 at the latest.

Article 3

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 6 July 2022 at the latest.

Article 4

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, 16 March 2021.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  Commission Implementing Regulation (EU) No 595/2012 of 5 July 2012 approving the active substance fenpyrazamine, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 176, 6.7.2012, p. 46).

2

(3)  EFSA (European Food Safety Authority), 2015. Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment of confirmatory data for the active substance fenpyrazamine. EFSA supporting publication 2014:EN-630.

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

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ANNEX

The column ‘Purity’ of row 25, fenpyrazamine, of Part B of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:

‘≥ 960 g/kg

The following manufacturing impurity is of toxicological concern and must not exceed the following amount in the technical material:

Hydrazine: maximum content: < 0,0001 % (1 mg/kg)’

The column ‘Specific provisions’ of row 25, fenpyrazamine, of Part B of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:

‘PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpyrazamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 and the Standing Committee on Plants, Animals, Food and Feed on 18 May 2020 shall be taken into account. The purity given in this entry is based on a commercial plant production.’

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| 17.3.2021 | EN | Official Journal of the European Union | L 91/7 |
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17.3.2021

EN

Official Journal of the European Union

L 91/7

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COMMISSION IMPLEMENTING REGULATION (EU) 2021/460

of 16 March 2021

amending Annex I to Regulation (EC) No 798/2008 as regards the entry for Ukraine in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into and transit through the Union in relation to highly pathogenic avian influenza

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1), and in particular the introductory phrase of Article 8, the first subparagraph of paragraph 1 of Article 8, paragraph 4 of Article 8 and Article 9(4) thereof,

Having regard to Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (2), and in particular Articles 23(1), 24(2) and 25(2) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (‘the commodities’). It provides that the commodities are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto. |
| --- | --- |

(1)

Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (‘the commodities’). It provides that the commodities are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto.

| (2) | Regulation (EC) No 798/2008 also lays down the conditions for a third country, territory, zone or compartment to be considered as free from highly pathogenic avian influenza (HPAI). |
| --- | --- |

(2)

Regulation (EC) No 798/2008 also lays down the conditions for a third country, territory, zone or compartment to be considered as free from highly pathogenic avian influenza (HPAI).

| (3) | Ukraine is listed in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country from which imports into and transit through the Union of certain poultry commodities are authorised from certain parts of its territory depending on the presence of HPAI. That regionalisation was set out in Part 1 of Annex I to Regulation (EC) No 798/2008, as amended by Implementing Regulation (EU) 2020/352 (4), following the confirmation of an outbreak of HPAI of subtype H5N8 on 19 January 2020. |
| --- | --- |

(3)

Ukraine is listed in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country from which imports into and transit through the Union of certain poultry commodities are authorised from certain parts of its territory depending on the presence of HPAI. That regionalisation was set out in Part 1 of Annex I to Regulation (EC) No 798/2008, as amended by Implementing Regulation (EU) 2020/352 (4), following the confirmation of an outbreak of HPAI of subtype H5N8 on 19 January 2020.

| (4) | Following the outbreak of HPAI, Ukraine has implemented a stamping out policy in order to control and limit the spread of that disease. In addition, Ukraine completed the requisite cleaning and disinfection measures following the implementation of the stamping out policy on the poultry holding where the HPAI outbreak was confirmed in January 2020. Ukraine has submitted updated information on the epidemiological situation on its territory and the measures it has taken to prevent the further spread of HPAI, which were evaluated by the Commission. |
| --- | --- |

(4)

Following the outbreak of HPAI, Ukraine has implemented a stamping out policy in order to control and limit the spread of that disease. In addition, Ukraine completed the requisite cleaning and disinfection measures following the implementation of the stamping out policy on the poultry holding where the HPAI outbreak was confirmed in January 2020. Ukraine has submitted updated information on the epidemiological situation on its territory and the measures it has taken to prevent the further spread of HPAI, which were evaluated by the Commission.

| (5) | On the basis of that evaluation it is concluded that that outbreak has been cleared and that there is no risk associated with the introduction into the Union of poultry commodities from the areas of Ukraine listed in Part 1 of Annex I to Regulation (EC) No 798/2008 from where imports have been suspended by that Regulation, as amended by Implementing Regulation (EU) 2020/352. |
| --- | --- |

(5)

On the basis of that evaluation it is concluded that that outbreak has been cleared and that there is no risk associated with the introduction into the Union of poultry commodities from the areas of Ukraine listed in Part 1 of Annex I to Regulation (EC) No 798/2008 from where imports have been suspended by that Regulation, as amended by Implementing Regulation (EU) 2020/352.

| (6) | On 4 December 2020, however, Ukraine confirmed the presence of HPAI of subtype H5 in a poultry holding on its territory. Due to that confirmed outbreak of HPAI, the whole territory of Ukraine can no longer be considered as free from that disease and the veterinary authorities of Ukraine can, therefore, no longer certify consignments of poultry commodities for import into, or transit through, the Union from the areas concerned by that outbreak. Following that outbreak, Ukraine has confirmed further HPAI outbreaks of subtype H5 in poultry holdings on its territory. |
| --- | --- |

(6)

On 4 December 2020, however, Ukraine confirmed the presence of HPAI of subtype H5 in a poultry holding on its territory. Due to that confirmed outbreak of HPAI, the whole territory of Ukraine can no longer be considered as free from that disease and the veterinary authorities of Ukraine can, therefore, no longer certify consignments of poultry commodities for import into, or transit through, the Union from the areas concerned by that outbreak. Following that outbreak, Ukraine has confirmed further HPAI outbreaks of subtype H5 in poultry holdings on its territory.

| (7) | The veterinary authorities of Ukraine have confirmed that following the outbreak in December 2020, they suspended issuing certificates for consignments of commodities intended for import into, or transit through, the Union and implemented a stamping-out policy in order to control HPAI and limit the spread of that disease. |
| --- | --- |

(7)

The veterinary authorities of Ukraine have confirmed that following the outbreak in December 2020, they suspended issuing certificates for consignments of commodities intended for import into, or transit through, the Union and implemented a stamping-out policy in order to control HPAI and limit the spread of that disease.

| (8) | Furthermore, Ukraine has submitted information to the Commission on the epidemiological situation on its territory and indicated the areas placed under restrictions as well as the measures it has taken to prevent the further spread of HPAI outside those restricted areas. That information has now been evaluated by the Commission and on the basis of that evaluation, as well as the guarantees provided by Ukraine, it should be concluded that limiting the restrictions on the introduction into the Union of consignments of poultry commodities to the areas affected by HPAI, which the veterinary authorities of Ukraine have placed under restrictions due to the current outbreaks, should be sufficient to cover the risks associated with the introduction into the Union of such commodities. |
| --- | --- |

(8)

Furthermore, Ukraine has submitted information to the Commission on the epidemiological situation on its territory and indicated the areas placed under restrictions as well as the measures it has taken to prevent the further spread of HPAI outside those restricted areas. That information has now been evaluated by the Commission and on the basis of that evaluation, as well as the guarantees provided by Ukraine, it should be concluded that limiting the restrictions on the introduction into the Union of consignments of poultry commodities to the areas affected by HPAI, which the veterinary authorities of Ukraine have placed under restrictions due to the current outbreaks, should be sufficient to cover the risks associated with the introduction into the Union of such commodities.

| (9) | The entry for Ukraine in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 should, therefore, be amended to take account of the current epidemiological situation in that third country. |
| --- | --- |

(9)

The entry for Ukraine in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 should, therefore, be amended to take account of the current epidemiological situation in that third country.

| (10) | Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly. |
| --- | --- |

(10)

Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(11)

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

Part 1 of Annex I to Regulation (EC) No 798/2008 is amended in accordance with the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 16 March 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 18, 23.1.2003, p. 11.

1

(2)  
  OJ L 343, 22.12.2009, p. 74.

2

(3)  Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1).

3

(4)  Commission Implementing Regulation (EU) 2020/352 of 3 March 2020 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for Ukraine in the lists of third countries, territories, zones or compartments from which certain poultry commodities may be imported into and transit through the Union in relation to highly pathogenic avian influenza (OJ L 65, 4.3.2020, p. 4).

4

---

ANNEX

In Part 1 of Annex I to Regulation (EC) No 798/2008, the entry for Ukraine is replaced by the following:

| ISO code and name of third country or territory | Code of third country, territory, zone or compartment | Description of third country, territory, zone or compartment | Veterinary certificate | Specific conditions | Specific conditions | Avian influenza surveillance status | Avian influenza vaccination status | Salmonella control status |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Model(s) | Additional guarantees | Closing date | Opening date |
| 1 | 2 | 3 | 4 | 5 | 6 | 6A | 6B | 7 | 8 | 9 |
| ‘UA – Ukraine | UA-0 | Whole country | EP, E | | | | | | | |
| UA-1 | The whole country of Ukraine excluding area UA-2 | WGM | | | | | | | |
| POU, RAT | | | | | | | |
| UA-2 | Area of Ukraine corresponding to: | | | | | | | | |
| UA-2.1 | Kherson Oblast (region) | WGM | | P2 | 30.11.2016 | 7.3.2020 | | | |
| POU, RAT | | P2 | 30.11.2016 | 7.3.2020 | | | |
| UA-2.2 | Odessa Oblast (region) | WGM | | P2 | 4.1.2017 | 7.3.2020 | | | |
| POU, RAT | | P2 | 4.1.2017 | 7.3.2020 | | | |
| UA-2.3 | Chernivtsi Oblast (region) | WGM | | P2 | 4.1.2017 | 7.3.2020 | | | |
| POU, RAT | | P2 | 4.1.2017 | 7.3.2020 | | | |
| UA-2.4 | Vinnytsia Oblast (region), Nemyriv Raion (district), municipalities:
  Berezivka village
  Bratslav village
  Budky village
  Bugakiv village
  Chervone village
  Chukiv village
  Danylky village
  Dovzhok village
  Horodnytsia village
  Hrabovets village
  Hranitne village
  Karolina village
  Korovayna village
  Korzhiv village
  Korzhivka village
  Kryklivtsi village
  Maryanivka village
  Melnykivtsi village
  Monastyrok village
  Monastyrske village
  Nemyriv City
  Novi Obyhody village
  Ostapkivtsi village
  Ozero village
  Perepelychcha village
  Rachky village
  Salyntsi village
  Samchyntsi village
  Sazhky village
  Selevintsi village
  Sholudky village
  Slobidka village
  Sorokoduby village
  Sorokotiazhyntsi village
  Velyka Bushynka village
  Vovchok village
  Vyhnanka village
  Yosypenky village
  Zarudyntsi village
  Zelenianka village | WGM | | P2 | 19.1.2020 | 20.3.2021 | | | |
| POU, RAT | | P2 | 19.1.2020 | 20.3.2021’ | | | |
| UA-2.5 | Mykolaiv Oblast (region)
  Kherson Oblast (region), Khersonskyi (Bilozerskyi) Raion (district), municipalities:
  Tavriyske village
  Nova zoria village | WGM | | P2 | 4.12.2020 | | | | |
| POU, RAT | | P2 | 4.12.2020 | | | | |
| UA-2.6 | Kyiv Oblast (region):
  Ivankiv Raion (district),
  municipalities:
  Leonivka village
  Blidcha village
  Kolentsi village
  Zymovyshche village
  Rudnia-Talska village
  Sosnivka village
  Borodianka Raion (district), municipalities:
  Koblytsia village
  Talske village
  Myrcha village
  Stara Buda village,
  Velykyi Lis village
  Krasnyi Rih village
  Mykhailivskyi small village | WGM | | P2 | 24.12.2020 | | | | |
| POU, RAT | | P2 | 24.12.2020 | | | | |
| UA-2.7 | Kyiv Oblast (region):
  Borodianka Raion (district), municipalities:
  Borodianka town
  Kachaly village
  Shybene village
  Nebrat village
  Nove Zalissia village
  Berestianka village
  Zdvyzhivka village
  Babyntsi village
  Buda-Babynetska village
  Klavdiyevo-Tarasove town
  Poroskoten village
  Pylypovychi village
  Nova Hreblia village
  Vablia village
  Druzhnia village
  Halynka village
  Zahaltsi village
  Mykhailivskyi (Mykhailenkiv) village
  country estate “Blyzhni sady”
  Buchanskyi Raion (district), municipalities: Nemishayeve town
  Mykulychi village
  Dibrova village
  Kozyntsi village
  Chervona hilka village
  Plakhtianka village
  Myrotske village
  part of Vorzel town restricted by Bilostotskykh and Pushkina str. | WGM | | P2 | 27.12.2020 | | | | |
| POU, RAT | | P2 | 27.12.2020 | | | | |
| UA-2.8 | Kherson Oblast (region):
  Kakhovskyi Raion (district), municipalities:
  Zaozerne village
  Skvortsivka village
  Maryanivka village
  Slynenko village
  Olhivka village
  Novotroyitskyi Raion (district), municipalities:
  Volodymyro-Ilyinka village
  Sofiivka village
  Katerynivka village | WGM | | P2 | 29.12.2020 | | | | |
| POU, RAT | | P2 | 29.12.2020 | | | | |
| UA-2.9 | Kyiv Oblast (region), Kyiv city:
  The area contained within a circle of a 10 km radius centred on Hostomel village of Buchanskyi Raion, and extending in a clockwise fashion:






  (a) | North, Northwest, West, Southwest: Kyiv region (oblast), Buchanskyi Raion (district), municipalities: Moshchun village, Hostomel town, Kotsiubynske town, Irpin city, Bucha city, Horenka village. |

ISO code and name of third country or territory

Code of third country, territory, zone or compartment

Description of third country, territory, zone or compartment

Veterinary certificate

Specific conditions

Specific conditions

Avian influenza surveillance status

Avian influenza vaccination status

Salmonella control status

Model(s)

Additional guarantees

Closing date

Opening date

1

2

3

4

5

6

6A

6B

7

8

9

‘UA – Ukraine

UA-0

Whole country

EP, E

UA-1

The whole country of Ukraine excluding area UA-2

WGM

POU, RAT

UA-2

Area of Ukraine corresponding to:

UA-2.1

Kherson Oblast (region)

WGM

P2

30.11.2016

7.3.2020

POU, RAT

P2

30.11.2016

7.3.2020

UA-2.2

Odessa Oblast (region)

WGM

P2

4.1.2017

7.3.2020

POU, RAT

P2

4.1.2017

7.3.2020

UA-2.3

Chernivtsi Oblast (region)

WGM

P2

4.1.2017

7.3.2020

POU, RAT

P2

4.1.2017

7.3.2020

UA-2.4

Vinnytsia Oblast (region), Nemyriv Raion (district), municipalities:

Berezivka village

Bratslav village

Budky village

Bugakiv village

Chervone village

Chukiv village

Danylky village

Dovzhok village

Horodnytsia village

Hrabovets village

Hranitne village

Karolina village

Korovayna village

Korzhiv village

Korzhivka village

Kryklivtsi village

Maryanivka village

Melnykivtsi village

Monastyrok village

Monastyrske village

Nemyriv City

Novi Obyhody village

Ostapkivtsi village

Ozero village

Perepelychcha village

Rachky village

Salyntsi village

Samchyntsi village

Sazhky village

Selevintsi village

Sholudky village

Slobidka village

Sorokoduby village

Sorokotiazhyntsi village

Velyka Bushynka village

Vovchok village

Vyhnanka village

Yosypenky village

Zarudyntsi village

Zelenianka village

WGM

P2

19.1.2020

20.3.2021

POU, RAT

P2

19.1.2020

20.3.2021’

UA-2.5

Mykolaiv Oblast (region)

Kherson Oblast (region), Khersonskyi (Bilozerskyi) Raion (district), municipalities:

Tavriyske village

Nova zoria village

WGM

P2

4.12.2020

POU, RAT

P2

4.12.2020

UA-2.6

Kyiv Oblast (region):

Ivankiv Raion (district),

municipalities:

Leonivka village

Blidcha village

Kolentsi village

Zymovyshche village

Rudnia-Talska village

Sosnivka village

Borodianka Raion (district), municipalities:

Koblytsia village

Talske village

Myrcha village

Stara Buda village,

Velykyi Lis village

Krasnyi Rih village

Mykhailivskyi small village

WGM

P2

24.12.2020

POU, RAT

P2

24.12.2020

UA-2.7

Kyiv Oblast (region):

Borodianka Raion (district), municipalities:

Borodianka town

Kachaly village

Shybene village

Nebrat village

Nove Zalissia village

Berestianka village

Zdvyzhivka village

Babyntsi village

Buda-Babynetska village

Klavdiyevo-Tarasove town

Poroskoten village

Pylypovychi village

Nova Hreblia village

Vablia village

Druzhnia village

Halynka village

Zahaltsi village

Mykhailivskyi (Mykhailenkiv) village

country estate “Blyzhni sady”

Buchanskyi Raion (district), municipalities: Nemishayeve town

Mykulychi village

Dibrova village

Kozyntsi village

Chervona hilka village

Plakhtianka village

Myrotske village

part of Vorzel town restricted by Bilostotskykh and Pushkina str.

WGM

P2

27.12.2020

POU, RAT

P2

27.12.2020

UA-2.8

Kherson Oblast (region):

Kakhovskyi Raion (district), municipalities:

Zaozerne village

Skvortsivka village

Maryanivka village

Slynenko village

Olhivka village

Novotroyitskyi Raion (district), municipalities:

Volodymyro-Ilyinka village

Sofiivka village

Katerynivka village

WGM

P2

29.12.2020

POU, RAT

P2

29.12.2020

UA-2.9

Kyiv Oblast (region), Kyiv city:

The area contained within a circle of a 10 km radius centred on Hostomel village of Buchanskyi Raion, and extending in a clockwise fashion:

(a)

North, Northwest, West, Southwest: Kyiv region (oblast), Buchanskyi Raion (district), municipalities: Moshchun village, Hostomel town, Kotsiubynske town, Irpin city, Bucha city, Horenka village.

| (b) | Northeast, East, Southeast, South: Boundary of Kyiv Region (oblast) with Obolonskyi, Podilskyi, Shevchenkivskyi Raions (districts) of Kyiv city from intersection of Polarna str., Avtozavodska Str., Semena Skliarenko str. the intersection with the Oleny Telihy str., Oleksandra Dovzhenko str. to the intersection with Peremohy Avenue |
| --- | --- |

(b)

Northeast, East, Southeast, South: Boundary of Kyiv Region (oblast) with Obolonskyi, Podilskyi, Shevchenkivskyi Raions (districts) of Kyiv city from intersection of Polarna str., Avtozavodska Str., Semena Skliarenko str. the intersection with the Oleny Telihy str., Oleksandra Dovzhenko str. to the intersection with Peremohy Avenue

WGM

P2

18.1.2021

POU, RAT

P2

18.1.2021

UA-2.10

Donetsk Oblast (region):

Volnovaskyi (ex Velykonovosilkivskyi) district, municipalities:

Vesele village

Fedorivka village

Skudne village

Dniproenerhiia village

Velyka Novosilka town

Rozdolne village

Novyi Komar village

Perebudova village

Novoocheretuvate village

Myrne village

Ordadne village

Komar village

Vremivka village

Voskresenka village

Vilne Pole village

Shevchenko village

Burlatske village

Pryvilne village

Dnipropetrovsk Oblast (region):

Prokrovskyi district, municipalities:

Maliivka village

WGM

P2

3.2.2021

POU, RAT

P2

3.2.2021

---

| 17.3.2021 | EN | Official Journal of the European Union | L 91/14 |
| --- | --- | --- | --- |

17.3.2021

EN

Official Journal of the European Union

L 91/14

---

COMMISSION IMPLEMENTING REGULATION (EU) 2021/461

of 16 March 2021

amending Regulation (EC) No 1235/2008 as regards the date for receiving requests for the recognition of control authorities and control bodies for the purpose of equivalence under the arrangements for imports of organic products based on Council Regulation (EC) No 834/2007

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (1), and in particular Article 33(3) and Article 38(d) thereof,

Whereas:

| (1) | Regulation (EU) 2018/848 of the European Parliament and of the Council (2) establishes that the scheme of control authorities and control bodies recognised by the Commission on the basis of Article 33(3) of Regulation (EC) No 834/2007 to carry out controls and to issue certificates in third countries for the purpose of importing products with equivalent guarantees will be replaced by a scheme of control authorities and control bodies recognised by the Commission for the purpose of importing compliant products. |
| --- | --- |

(1)

Regulation (EU) 2018/848 of the European Parliament and of the Council (2) establishes that the scheme of control authorities and control bodies recognised by the Commission on the basis of Article 33(3) of Regulation (EC) No 834/2007 to carry out controls and to issue certificates in third countries for the purpose of importing products with equivalent guarantees will be replaced by a scheme of control authorities and control bodies recognised by the Commission for the purpose of importing compliant products.

| (2) | Due to the outbreak of the COVID-19 pandemic and the related public health crisis, the date of application of Regulation (EU) 2018/848 and certain other dates referred to in that Regulation were deferred by one year by Regulation (EU) 2020/1693 of the European Parliament and of the Council (3). As a result, Regulation (EU) 2018/848 will apply from 1 January 2022. |
| --- | --- |

(2)

Due to the outbreak of the COVID-19 pandemic and the related public health crisis, the date of application of Regulation (EU) 2018/848 and certain other dates referred to in that Regulation were deferred by one year by Regulation (EU) 2020/1693 of the European Parliament and of the Council (3). As a result, Regulation (EU) 2018/848 will apply from 1 January 2022.

| (3) | In order to ensure that the necessary administrative capacities were available to provide for a timely recognition of control authorities and control bodies under the new scheme, Article 11(1) of Commission Regulation (EC) No 1235/2008 (4) was amended by Implementing Regulation (EU) 2020/25 (5) in order to introduce a final date for receiving new requests for the recognition of control authorities and control bodies for the purpose of equivalence under the old scheme. That final date is 30 June 2020. |
| --- | --- |

(3)

In order to ensure that the necessary administrative capacities were available to provide for a timely recognition of control authorities and control bodies under the new scheme, Article 11(1) of Commission Regulation (EC) No 1235/2008 (4) was amended by Implementing Regulation (EU) 2020/25 (5) in order to introduce a final date for receiving new requests for the recognition of control authorities and control bodies for the purpose of equivalence under the old scheme. That final date is 30 June 2020.

| (4) | It is therefore necessary to amend Article 11(1) of Regulation (EC) No 1235/2008 once again in order to align the date for receiving new requests for the recognition of control authorities and control bodies for the purpose of equivalence under the old import scheme with the date of the establishment of the new import system in Regulation (EU) 2018/848. |
| --- | --- |

(4)

It is therefore necessary to amend Article 11(1) of Regulation (EC) No 1235/2008 once again in order to align the date for receiving new requests for the recognition of control authorities and control bodies for the purpose of equivalence under the old import scheme with the date of the establishment of the new import system in Regulation (EU) 2018/848.

| (5) | Regulation (EC) No 1235/2008 should therefore be amended accordingly. |
| --- | --- |

(5)

Regulation (EC) No 1235/2008 should therefore be amended accordingly.

| (6) | In order to give the control authorities and control bodies concerned the opportunity to benefit fully from the time period left until 30 June 2021 after the relevant IT tool has been reactivated, this Regulation should enter into force as a matter of urgency on the day following that of its publication in the Official Journal of the European Union. |
| --- | --- |

(6)

In order to give the control authorities and control bodies concerned the opportunity to benefit fully from the time period left until 30 June 2021 after the relevant IT tool has been reactivated, this Regulation should enter into force as a matter of urgency on the day following that of its publication in the Official Journal of the European Union.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Committee on organic production, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on organic production,

HAS ADOPTED THIS REGULATION:

Article 1

In Article 11(1) of Regulation (EC) No 1235/2008, the date ‘30 June 2020’ is replaced by ‘30 June 2021’.

Article 2

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, 16 March 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 189, 20.7.2007, p. 1.

1

(2)  Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).

2

(3)  Regulation (EU) 2020/1693 of the European Parliament and of the Council of 11 November 2020 amending Regulation (EU) 2018/848 as regards its date of application and certain other dates referred to in that Regulation (OJ L 381, 13.11.2020, p. 1).

3

(4)  Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries (OJ L 334 12.12.2008, p. 25).

4

(5)  Commission Implementing Regulation (EU) 2020/25 of 13 January 2020 amending and correcting Regulation (EC) No 1235/2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries (OJ L 8, 14.1.2020, p. 18).

5

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