# Official Journal L 173/2021

| | ISSN 1977-0677 |
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| Official Journal
  of the European Union | L 173 |
| | |
| English edition | Legislation | Volume 6417 May 2021 |

ISSN 1977-0677

Official Journal

of the European Union

L 173

English edition

Legislation

Volume 6417 May 2021

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | DECISIONS |
| | * | Council Implementing Decision (EU) 2021/786 of 10 May 2021 authorising the Republic of Croatia to apply a tax exemption to gas oil used to operate machinery in humanitarian demining in accordance with Article 19 of Directive 2003/96/EC | 1 |
| | * | Commission Implementing Decision (EU) 2021/787 of 12 May 2021 authorising Lithuania to refuse to grant exemption from excise duty in relation to certain mouthwash products and cosmetic spirits in accordance with Council Directive 92/83/EEC
  (notified under document C(2021) 3260) | 3 |
| | * | Commission Implementing Decision (EU) 2021/788 of 12 May 2021 laying down rules for the monitoring and reporting of infections with SARS-CoV-2 in certain animal species
  (notified under document C(2021) 3293)

   (
  1
  ) | 6 |
| | * | Decision (EU) 2021/789 of the Single Resolution Board of 31 March 2021 on discharge in respect of the implementation of the budget and on the closure of the accounts of the Single Resolution Board (SRB) for the financial year 2019 (SRB/PS/2021/03) | 15 |

Contents

II   Non-legislative acts

page

DECISIONS

*

Council Implementing Decision (EU) 2021/786 of 10 May 2021 authorising the Republic of Croatia to apply a tax exemption to gas oil used to operate machinery in humanitarian demining in accordance with Article 19 of Directive 2003/96/EC

1

*

Commission Implementing Decision (EU) 2021/787 of 12 May 2021 authorising Lithuania to refuse to grant exemption from excise duty in relation to certain mouthwash products and cosmetic spirits in accordance with Council Directive 92/83/EEC
  (notified under document C(2021) 3260)

(notified under document C(2021) 3260)

3

*

Commission Implementing Decision (EU) 2021/788 of 12 May 2021 laying down rules for the monitoring and reporting of infections with SARS-CoV-2 in certain animal species
  (notified under document C(2021) 3293)

   (
  1
  )

(notified under document C(2021) 3293)

1

6

*

Decision (EU) 2021/789 of the Single Resolution Board of 31 March 2021 on discharge in respect of the implementation of the budget and on the closure of the accounts of the Single Resolution Board (SRB) for the financial year 2019 (SRB/PS/2021/03)

15

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| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

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

EN

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

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

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II Non-legislative acts

DECISIONS

| 17.5.2021 | EN | Official Journal of the European Union | L 173/1 |
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17.5.2021

EN

Official Journal of the European Union

L 173/1

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COUNCIL IMPLEMENTING DECISION (EU) 2021/786

of 10 May 2021

authorising the Republic of Croatia to apply a tax exemption to gas oil used to operate machinery in humanitarian demining in accordance with Article 19 of Directive 2003/96/EC

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to Council Directive 2003/96/EC of 27 October 2003 restructuring the Community framework for the taxation of energy products and electricity (1), and in particular Article 19 thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | By Council Implementing Decision 2014/921/EU (2), Croatia was authorised to apply a tax exemption to gas oil used to operate specialised machinery in humanitarian demining in accordance with Article 19 of Directive 2003/96/EC (the ‘tax exemption’) until 19 December 2020. |
| --- | --- |

(1)

By Council Implementing Decision 2014/921/EU (2), Croatia was authorised to apply a tax exemption to gas oil used to operate specialised machinery in humanitarian demining in accordance with Article 19 of Directive 2003/96/EC (the ‘tax exemption’) until 19 December 2020.

| (2) | On 18 September 2020, Croatia requested authorisation to continue to apply the tax exemption for the period from 20 December 2020 until 19 December 2026. At the request of the Commission, Croatia provided additional supporting information on 13 October and 6 November 2020. |
| --- | --- |

(2)

On 18 September 2020, Croatia requested authorisation to continue to apply the tax exemption for the period from 20 December 2020 until 19 December 2026. At the request of the Commission, Croatia provided additional supporting information on 13 October and 6 November 2020.

| (3) | With the tax exemption it intends to continue to apply, Croatia aims to speed up the demining of the remaining mine-contaminated areas in various regions. The tax exemption would have immediate positive effects on human life and health in those regions. |
| --- | --- |

(3)

With the tax exemption it intends to continue to apply, Croatia aims to speed up the demining of the remaining mine-contaminated areas in various regions. The tax exemption would have immediate positive effects on human life and health in those regions.

| (4) | The tax exemption should be limited to accredited special-purpose machines designed and built specifically for clearing mined areas. |
| --- | --- |

(4)

The tax exemption should be limited to accredited special-purpose machines designed and built specifically for clearing mined areas.

| (5) | The tax exemption should be limited to mine-contaminated areas in the territory of Croatia. |
| --- | --- |

(5)

The tax exemption should be limited to mine-contaminated areas in the territory of Croatia.

| (6) | The tax exemption should apply to all operators involved in humanitarian demining in Croatia, thus no economic advantage will be given to any particular operator involved. |
| --- | --- |

(6)

The tax exemption should apply to all operators involved in humanitarian demining in Croatia, thus no economic advantage will be given to any particular operator involved.

| (7) | Consequently, the tax exemption is acceptable from the point of view of the proper functioning of the internal market and of the need to ensure fair competition and it is compatible with the Union’s health, environment, energy and transport policies. |
| --- | --- |

(7)

Consequently, the tax exemption is acceptable from the point of view of the proper functioning of the internal market and of the need to ensure fair competition and it is compatible with the Union’s health, environment, energy and transport policies.

| (8) | Each authorisation granted under Article 19(1) of Directive 2003/96/EC is to be strictly limited in time. In order to provide economic operators concerned with a sufficient degree of certainty and enough time to conclude the process of demining of the contaminated areas, it is appropriate to grant the authorisation for a period of six years. |
| --- | --- |

(8)

Each authorisation granted under Article 19(1) of Directive 2003/96/EC is to be strictly limited in time. In order to provide economic operators concerned with a sufficient degree of certainty and enough time to conclude the process of demining of the contaminated areas, it is appropriate to grant the authorisation for a period of six years.

| (9) | In order to provide legal certainty to economic operators involved in demining operations and to avoid a potential increase in the administrative burden resulting from changes to the applicable tax rate, Croatia should be able to apply the tax exemption without interruption. The authorisation requested should therefore be granted with effect from 20 December 2020, in order to follow seamlessly on from the prior arrangements under Implementing Decision 2014/921/EU. |
| --- | --- |

(9)

In order to provide legal certainty to economic operators involved in demining operations and to avoid a potential increase in the administrative burden resulting from changes to the applicable tax rate, Croatia should be able to apply the tax exemption without interruption. The authorisation requested should therefore be granted with effect from 20 December 2020, in order to follow seamlessly on from the prior arrangements under Implementing Decision 2014/921/EU.

| (10) | This Decision is without prejudice to the application of Union rules regarding State aid, |
| --- | --- |

(10)

This Decision is without prejudice to the application of Union rules regarding State aid,

HAS ADOPTED THIS DECISION:

Article 1

Croatia is authorised to exempt from taxation gas oil used to operate machinery in humanitarian demining in its territory. The tax exemption shall be limited to accredited special-purpose machines designed and built specifically for clearing mined areas.

Article 2

This Decision shall apply from 20 December 2020 until 19 December 2026.

However, should the Council, acting on the basis of Article 113 or any other relevant provision of the Treaty, provide for general rules on tax advantages for humanitarian demining, this Decision shall cease to apply on the day on which those general rules become applicable.

Article 3

This Decision is addressed to the Republic of Croatia.

Done at Brussels, 10 May 2021.

For the Council

The President

J. BORRELL FONTELLES

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(1)  
  OJ L 283, 31.10.2003, p. 51.

1

(2)  Council Implementing Decision 2014/921/EU of 16 December 2014 authorising Croatia to apply a tax exemption to gas oil used to operate machinery in humanitarian demining in accordance with Article 19 of Directive 2003/96/EC (OJ L 363, 18.12.2014, p. 150).

2

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| 17.5.2021 | EN | Official Journal of the European Union | L 173/3 |
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17.5.2021

EN

Official Journal of the European Union

L 173/3

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COMMISSION IMPLEMENTING DECISION (EU) 2021/787

of 12 May 2021

authorising Lithuania to refuse to grant exemption from excise duty in relation to certain mouthwash products and cosmetic spirits in accordance with Council Directive 92/83/EEC

(notified under document C(2021) 3260)

(Only the Lithuanian text is authentic)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 92/83/EEC of 19 October 1992 on the harmonization of the structures of excise duties on alcohol and alcoholic beverages (1), and in particular Article 27(5) thereof,

Whereas:

| (1) | The purpose of Directive 92/83/EEC is to create, in the field of alcohol taxation, conditions ensuring the establishment and functioning of the internal market. Article 27(1) of Directive 92/83/EEC specifies the products covered by that Directive, which are to be exempt from excise duty by Member States. Article 27(1)(b) of Directive 92/83/EEC provides for exemption for denatured products covered by that Directive used for the manufacture of any product not for human consumption. The system laid down in Directive 92/83/EEC is that of mutual acceptance. Once a product falling under Article 27(1)(b) of Directive 92/83/EEC has been exempted from excise duty in any Member State it may move freely throughout the Union without being subject to excise duty. Article 27(5) of Directive 92/83/EEC allows Member States to refuse to grant such exemption if the product concerned gives rise to evasion, avoidance or abuse. |
| --- | --- |

(1)

The purpose of Directive 92/83/EEC is to create, in the field of alcohol taxation, conditions ensuring the establishment and functioning of the internal market. Article 27(1) of Directive 92/83/EEC specifies the products covered by that Directive, which are to be exempt from excise duty by Member States. Article 27(1)(b) of Directive 92/83/EEC provides for exemption for denatured products covered by that Directive used for the manufacture of any product not for human consumption. The system laid down in Directive 92/83/EEC is that of mutual acceptance. Once a product falling under Article 27(1)(b) of Directive 92/83/EEC has been exempted from excise duty in any Member State it may move freely throughout the Union without being subject to excise duty. Article 27(5) of Directive 92/83/EEC allows Member States to refuse to grant such exemption if the product concerned gives rise to evasion, avoidance or abuse.

| (2) | By letter of 3 June 2016, Lithuania notified the Commission, in accordance with Article 27(5) of Directive 92/83/EEC, of its refusal to grant the exemption from excise duty provided for in Article 27(1)(b) of Directive 92/83/EEC for ethyl alcohol denatured with isopropyl alcohol with a quantity of 10 litres or less per 1 hectolitre of absolute ethyl alcohol used in certain mouthwash products and cosmetic spirits (‘the products concerned’). Lithuania is of the opinion that the products concerned have given rise to evasion, avoidance and abuse in Lithuania. |
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(2)

By letter of 3 June 2016, Lithuania notified the Commission, in accordance with Article 27(5) of Directive 92/83/EEC, of its refusal to grant the exemption from excise duty provided for in Article 27(1)(b) of Directive 92/83/EEC for ethyl alcohol denatured with isopropyl alcohol with a quantity of 10 litres or less per 1 hectolitre of absolute ethyl alcohol used in certain mouthwash products and cosmetic spirits (‘the products concerned’). Lithuania is of the opinion that the products concerned have given rise to evasion, avoidance and abuse in Lithuania.

| (3) | The Commission transmitted the communication of Lithuania to the other Member States on 15 June 2016 and invited them to give their observations. |
| --- | --- |

(3)

The Commission transmitted the communication of Lithuania to the other Member States on 15 June 2016 and invited them to give their observations.

| (4) | At the meeting of the Committee on Excise Duty on 8 November 2016, Member States agreed that the Fiscalis Project Group on arrangements for completion of the work on completely and partially denatured alcohol needs to examine the denaturing formulations for cosmetic and personal care products and to provide an opinion on the formulation that is appropriate for those products. The Committee is to revisit the issue following the opinion of the Fiscalis Project Group. The Fiscalis Project Group noted that the same formulation as that used in the products concerned is used in many other products not intended for human consumption. However, those other products have not given rise to evasion, avoidance or abuse. The taxation of all products denatured with that formulation would therefore be disproportionate. The Commission therefore invited Lithuania, by letter of 21 January 2019, to provide a detailed description of the products concerned rather than the denaturing formulation. |
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(4)

At the meeting of the Committee on Excise Duty on 8 November 2016, Member States agreed that the Fiscalis Project Group on arrangements for completion of the work on completely and partially denatured alcohol needs to examine the denaturing formulations for cosmetic and personal care products and to provide an opinion on the formulation that is appropriate for those products. The Committee is to revisit the issue following the opinion of the Fiscalis Project Group. The Fiscalis Project Group noted that the same formulation as that used in the products concerned is used in many other products not intended for human consumption. However, those other products have not given rise to evasion, avoidance or abuse. The taxation of all products denatured with that formulation would therefore be disproportionate. The Commission therefore invited Lithuania, by letter of 21 January 2019, to provide a detailed description of the products concerned rather than the denaturing formulation.

| (5) | By letter of 21 August 2019, Lithuania provided additional information on the products concerned. The Commission transmitted this information to the other Member States. In its letter, Lithuania explained that the products concerned are the mouthwash products with the brand names ‘Classic’ and ‘Crystal’ and cosmetic spirits with the brand names ‘Yellow’, ‘Citrus’, ‘Green’, ‘Citrina’, ‘Red’, ‘Avietė’, ‘Blue’ and ‘Juodieji serbentai’, with alcoholic strengths by volume of approximately 20 % or 60 %, respectively. The products concerned are not used for the hygiene or cosmetic purposes indicated on the label. According to the letter, economic operators are marketing those products to vulnerable groups of the Lithuanian population for consumption as intoxicating alcoholic beverages without removing the toxic denaturant, which is detrimental to human health. The products concerned are used for human consumption and Lithuania therefore considers that they should not benefit from an exemption from excise duty. Lithuania concluded in its letter that this gives rise to abuse referred to in Article 27 of Directive 92/83/EEC. |
| --- | --- |

(5)

By letter of 21 August 2019, Lithuania provided additional information on the products concerned. The Commission transmitted this information to the other Member States. In its letter, Lithuania explained that the products concerned are the mouthwash products with the brand names ‘Classic’ and ‘Crystal’ and cosmetic spirits with the brand names ‘Yellow’, ‘Citrus’, ‘Green’, ‘Citrina’, ‘Red’, ‘Avietė’, ‘Blue’ and ‘Juodieji serbentai’, with alcoholic strengths by volume of approximately 20 % or 60 %, respectively. The products concerned are not used for the hygiene or cosmetic purposes indicated on the label. According to the letter, economic operators are marketing those products to vulnerable groups of the Lithuanian population for consumption as intoxicating alcoholic beverages without removing the toxic denaturant, which is detrimental to human health. The products concerned are used for human consumption and Lithuania therefore considers that they should not benefit from an exemption from excise duty. Lithuania concluded in its letter that this gives rise to abuse referred to in Article 27 of Directive 92/83/EEC.

| (6) | Moreover, Lithuania estimated that from 2009 to 2016 the total volume of the products concerned sold on the Lithuanian market was approximately 1 500 000 litres, which amounts to approximately EUR 11 500 000 in lost excise duty revenue, or 1 per cent of the total excise duty revenue from ethyl alcohol in Lithuania during that period. Lithuania concluded in its letter that this gives rise to abuse, evasion and avoidance referred to in Article 27 of Directive 92/83/EEC. |
| --- | --- |

(6)

Moreover, Lithuania estimated that from 2009 to 2016 the total volume of the products concerned sold on the Lithuanian market was approximately 1 500 000 litres, which amounts to approximately EUR 11 500 000 in lost excise duty revenue, or 1 per cent of the total excise duty revenue from ethyl alcohol in Lithuania during that period. Lithuania concluded in its letter that this gives rise to abuse, evasion and avoidance referred to in Article 27 of Directive 92/83/EEC.

| (7) | At the meeting of the Committee on Excise Duty on 15 November 2019, Member States discussed the taxation of the products and the evidence provided by Lithuania demonstrating the evasion, avoidance and abuse. Member States noted their support of addressing this issue in Lithuania. Moreover, Member States noted their support of addressing the serious risk that economic operators could easily modify the brand name of the products concerned or make other modifications in order to circumvent a refusal to grant exemption under Article 27(1)(b) of Directive 92/83/EEC. |
| --- | --- |

(7)

At the meeting of the Committee on Excise Duty on 15 November 2019, Member States discussed the taxation of the products and the evidence provided by Lithuania demonstrating the evasion, avoidance and abuse. Member States noted their support of addressing this issue in Lithuania. Moreover, Member States noted their support of addressing the serious risk that economic operators could easily modify the brand name of the products concerned or make other modifications in order to circumvent a refusal to grant exemption under Article 27(1)(b) of Directive 92/83/EEC.

| (8) | The Commission considers that the consumption of the products concerned as intoxicating alcoholic beverages constitutes improper use with serious negative implications for health and for tax revenues. |
| --- | --- |

(8)

The Commission considers that the consumption of the products concerned as intoxicating alcoholic beverages constitutes improper use with serious negative implications for health and for tax revenues.

| (9) | The economic operators marketing the products concerned benefit from a more favourable excise duty regime than that applicable to alcoholic beverages. Lithuania has also demonstrated significant loss of excise duty revenue from ethyl alcohol used in the products concerned. Based on the evidence provided by Lithuania, which by its nature is difficult to obtain, and based on the estimates of lost excise duty revenue, the Commission considers that the products concerned give rise to evasion, avoidance and abuse. |
| --- | --- |

(9)

The economic operators marketing the products concerned benefit from a more favourable excise duty regime than that applicable to alcoholic beverages. Lithuania has also demonstrated significant loss of excise duty revenue from ethyl alcohol used in the products concerned. Based on the evidence provided by Lithuania, which by its nature is difficult to obtain, and based on the estimates of lost excise duty revenue, the Commission considers that the products concerned give rise to evasion, avoidance and abuse.

| (10) | Given that the products concerned give rise to evasion, avoidance and abuse, Lithuania should be authorised to refuse to grant exemption under Article 27(1)(b) of Directive 92/83/EEC to those products. |
| --- | --- |

(10)

Given that the products concerned give rise to evasion, avoidance and abuse, Lithuania should be authorised to refuse to grant exemption under Article 27(1)(b) of Directive 92/83/EEC to those products.

| (11) | Moreover, the Commission is of the opinion that the economic operators manufacturing the products concerned could easily circumvent a refusal to grant exemption under Article 27(1)(b) of Directive 92/83/EEC by modifying an element of the products concerned, such as the brand name. In order to prevent such circumvention, Lithuania should also be authorised to refuse to grant such an exemption to any other similar liquid cosmetic spirits and mouthwash products that are consumed as alcoholic beverages. |
| --- | --- |

(11)

Moreover, the Commission is of the opinion that the economic operators manufacturing the products concerned could easily circumvent a refusal to grant exemption under Article 27(1)(b) of Directive 92/83/EEC by modifying an element of the products concerned, such as the brand name. In order to prevent such circumvention, Lithuania should also be authorised to refuse to grant such an exemption to any other similar liquid cosmetic spirits and mouthwash products that are consumed as alcoholic beverages.

| (12) | The measures provided for in this Decision are in accordance with the opinion of the Committee on Excise Duty, |
| --- | --- |

(12)

The measures provided for in this Decision are in accordance with the opinion of the Committee on Excise Duty,

HAS ADOPTED THIS DECISION:

Article 1

Lithuania is authorised to refuse to grant exemption from harmonised excise duty to ethyl alcohol denatured with isopropyl alcohol with a quantity of 10 litres or less per 1 hectolitre of absolute ethyl alcohol and used for the manufacture of the following liquid cosmetic spirits and mouthwash products, or any other similar liquid cosmetic spirits and mouthwash products, not intended for human consumption, but consumed as alcoholic beverages:

| (a) | mouthwash products with an alcoholic strength by volume exceeding 20 % with the brand names ‘Classic’ and ‘Crystal’; |
| --- | --- |

(a)

mouthwash products with an alcoholic strength by volume exceeding 20 % with the brand names ‘Classic’ and ‘Crystal’;

| (b) | cosmetic spirits with an alcoholic strength by volume exceeding 60 % with the brand names ‘Yellow’ , ‘Citrus’, ‘Green’, ‘Citrina’, ‘Red’, ‘Avietė’, ‘Blue’ and ‘Juodieji serbentai’. |
| --- | --- |

(b)

cosmetic spirits with an alcoholic strength by volume exceeding 60 % with the brand names ‘Yellow’ , ‘Citrus’, ‘Green’, ‘Citrina’, ‘Red’, ‘Avietė’, ‘Blue’ and ‘Juodieji serbentai’.

Article 2

This Decision is addressed to the Republic of Lithuania.

Done at Brussels, 12 May 2021.

For the Commission

Paolo GENTILONI

Member of the Commission

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(1)  
  OJ L 316, 31.10.1992, p. 21.

1

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| 17.5.2021 | EN | Official Journal of the European Union | L 173/6 |
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17.5.2021

EN

Official Journal of the European Union

L 173/6

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COMMISSION IMPLEMENTING DECISION (EU) 2021/788

of 12 May 2021

laying down rules for the monitoring and reporting of infections with SARS-CoV-2 in certain animal species

(notified under document C(2021) 3293)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (1), and in particular Articles 4(5) and 9(1) and Article 11, third paragraph, thereof,

Whereas:

| (1) | Since 2020, infections with the SARS-CoV-2 virus in minks have been reported in certain Member States and third countries, and it has been established that human-to-mink and mink-to-human transmission can occur. Furthermore, one Member State has reported human COVID-19 cases infected with the SARS-CoV-2 virus variants related to mink. |
| --- | --- |

(1)

Since 2020, infections with the SARS-CoV-2 virus in minks have been reported in certain Member States and third countries, and it has been established that human-to-mink and mink-to-human transmission can occur. Furthermore, one Member State has reported human COVID-19 cases infected with the SARS-CoV-2 virus variants related to mink.

| (2) | On 12 November 2020, the European Centre for Disease Prevention and Control (ECDC) published, with the contribution of the European Food Safety Authority (EFSA), a Rapid Risk Assessment on the detection of new SARS-CoV-2 variants related to mink (2) (the ECDC Rapid Risk Assessment). |
| --- | --- |

(2)

On 12 November 2020, the European Centre for Disease Prevention and Control (ECDC) published, with the contribution of the European Food Safety Authority (EFSA), a Rapid Risk Assessment on the detection of new SARS-CoV-2 variants related to mink (2) (the ECDC Rapid Risk Assessment).

| (3) | The ECDC Rapid Risk Assessment concluded that the overall level of risk to human health posed by SARS-CoV-2 mink-related variants can be determined as ranging from low for the general population up to very high for medically vulnerable individuals with occupational exposure. The ECDC Rapid Risk Assessment also indicated that further investigations are needed to assess whether SARS-CoV-2 mink-related variants may have an impact on the risk of reinfection, reduced vaccine efficacy or reduced benefit from treatment. |
| --- | --- |

(3)

The ECDC Rapid Risk Assessment concluded that the overall level of risk to human health posed by SARS-CoV-2 mink-related variants can be determined as ranging from low for the general population up to very high for medically vulnerable individuals with occupational exposure. The ECDC Rapid Risk Assessment also indicated that further investigations are needed to assess whether SARS-CoV-2 mink-related variants may have an impact on the risk of reinfection, reduced vaccine efficacy or reduced benefit from treatment.

| (4) | To decrease the risk posed to public health, the ECDC Rapid Risk Assessment recommends that national authorities should consider implementing measures aimed at mink farms, mink farm workers and communities in contact with mink farms. Those measures should cover human testing, sequencing and characterisation of antigenic properties and virus infectivity as well as animal monitoring and surveillance of mink farms in order to prevent the spread of SARS-CoV-2 variants from animals to humans. |
| --- | --- |

(4)

To decrease the risk posed to public health, the ECDC Rapid Risk Assessment recommends that national authorities should consider implementing measures aimed at mink farms, mink farm workers and communities in contact with mink farms. Those measures should cover human testing, sequencing and characterisation of antigenic properties and virus infectivity as well as animal monitoring and surveillance of mink farms in order to prevent the spread of SARS-CoV-2 variants from animals to humans.

| (5) | On 20 January 2021, the World Health Organization (WHO), the World Organisation for Animal Health (OIE) and the Food and Agriculture Organization of the United Nations (FAO) issued a joint tripartite risk assessment on emerging threats at the human-animal-ecosystems interface, which addressed SARS-CoV-2 in animals used for fur farming (3). The risk assessment recommends that the testing of animals for SARS-CoV-2 should be risk-based and should only be considered in the broader response to COVID-19 within a ‘One Health’ approach, incorporating an early warning and surveillance system based on case definitions in farm workers and animals as appropriate. In accordance with the risk assessment, in SARS-CoV-2 outbreaks involving fur farms, sequencing of viruses from human cases and minks, including phylogenetic analysis and comparison of genetic sequences, is recommended to understand the direction of infection (namely, whether animal to animal, animal to human, human to animal or human to human) and to identify and assess any mutations occurring. |
| --- | --- |

(5)

On 20 January 2021, the World Health Organization (WHO), the World Organisation for Animal Health (OIE) and the Food and Agriculture Organization of the United Nations (FAO) issued a joint tripartite risk assessment on emerging threats at the human-animal-ecosystems interface, which addressed SARS-CoV-2 in animals used for fur farming (3). The risk assessment recommends that the testing of animals for SARS-CoV-2 should be risk-based and should only be considered in the broader response to COVID-19 within a ‘One Health’ approach, incorporating an early warning and surveillance system based on case definitions in farm workers and animals as appropriate. In accordance with the risk assessment, in SARS-CoV-2 outbreaks involving fur farms, sequencing of viruses from human cases and minks, including phylogenetic analysis and comparison of genetic sequences, is recommended to understand the direction of infection (namely, whether animal to animal, animal to human, human to animal or human to human) and to identify and assess any mutations occurring.

| (6) | On 18 February 2021, EFSA, with the contribution of ECDC, published the scientific report on the monitoring of SARS-CoV-2 infection in mustelids (4) (the EFSA report). The EFSA report indicates that SARS-CoV-2 spreads very efficiently within mink farms once introduced, by direct and indirect contact. Infected humans were likely at the origin of the introduction of SARS-CoV-2 infection into farms. The EFSA report concludes that carrying out surveillance on workers at mink farms is an important step in enabling the early detection of infection. The EFSA report also indicates that raccoon dogs (Nyctereutes procyonoides) are also susceptible to SARS-CoV-2. |
| --- | --- |

(6)

On 18 February 2021, EFSA, with the contribution of ECDC, published the scientific report on the monitoring of SARS-CoV-2 infection in mustelids (4) (the EFSA report). The EFSA report indicates that SARS-CoV-2 spreads very efficiently within mink farms once introduced, by direct and indirect contact. Infected humans were likely at the origin of the introduction of SARS-CoV-2 infection into farms. The EFSA report concludes that carrying out surveillance on workers at mink farms is an important step in enabling the early detection of infection. The EFSA report also indicates that raccoon dogs (Nyctereutes procyonoides) are also susceptible to SARS-CoV-2.

| (7) | The EFSA report recommends that all mink farms that are not yet infected should be considered at risk of infection, as the human disease is widespread and therefore the monitoring objective of choice should be early detection. |
| --- | --- |

(7)

The EFSA report recommends that all mink farms that are not yet infected should be considered at risk of infection, as the human disease is widespread and therefore the monitoring objective of choice should be early detection.

| (8) | In line with the EFSA report, one of the monitoring objectives should be the monitoring of the SARS-CoV-2 virus evolution. Genetic analysis is important to characterise the SARS-CoV-2 virus and to detect possible virus mutations and to identify the origin and the source of the virus. Detecting possible virus mutations is of particular relevance for public health, in order to identify new variant viruses early that may have an impact on diagnostics, transmission, severity or vaccine effectiveness. |
| --- | --- |

(8)

In line with the EFSA report, one of the monitoring objectives should be the monitoring of the SARS-CoV-2 virus evolution. Genetic analysis is important to characterise the SARS-CoV-2 virus and to detect possible virus mutations and to identify the origin and the source of the virus. Detecting possible virus mutations is of particular relevance for public health, in order to identify new variant viruses early that may have an impact on diagnostics, transmission, severity or vaccine effectiveness.

| (9) | Kept and wild raccoon dogs should be considered susceptible to SARS-CoV-2 infection. The OIE, in its Guidance on working with farmed animals of species susceptible to infection with SARS-CoV-2 (5), has called on countries to monitor susceptible animals for SARS-CoV-2 infection, such as mink and raccoon dogs, as well as humans in close contact with them, adopting a ‘One Health’ approach. Monitoring programmes concerning zoonoses should be established by the Commission for laying down detailed rules for the monitoring of this specific zoonotic agent as Directive 2003/99/EC provides for such monitoring in view of collecting coordinated data, make data easier to compile and compare and better identification of the risks, and thus enabling further action where appropriate. The recitals of that Directive mention that zoonoses transmitted through sources other than food, especially from wild animal and pet animal populations, are a matter of concern. In addition, they mention that the collection of data on the occurrence of zoonoses and zoonotic agents in animals, food, feed and humans is necessary to determine the trends and sources of zoonoses. They also mention that priority should be given to those zoonoses posing the greatest risk to human health, but that the monitoring systems should also facilitate the detection of emerging or newly emerging zoonotic diseases and new strains of zoonotic organisms. |
| --- | --- |

(9)

Kept and wild raccoon dogs should be considered susceptible to SARS-CoV-2 infection. The OIE, in its Guidance on working with farmed animals of species susceptible to infection with SARS-CoV-2 (5), has called on countries to monitor susceptible animals for SARS-CoV-2 infection, such as mink and raccoon dogs, as well as humans in close contact with them, adopting a ‘One Health’ approach. Monitoring programmes concerning zoonoses should be established by the Commission for laying down detailed rules for the monitoring of this specific zoonotic agent as Directive 2003/99/EC provides for such monitoring in view of collecting coordinated data, make data easier to compile and compare and better identification of the risks, and thus enabling further action where appropriate. The recitals of that Directive mention that zoonoses transmitted through sources other than food, especially from wild animal and pet animal populations, are a matter of concern. In addition, they mention that the collection of data on the occurrence of zoonoses and zoonotic agents in animals, food, feed and humans is necessary to determine the trends and sources of zoonoses. They also mention that priority should be given to those zoonoses posing the greatest risk to human health, but that the monitoring systems should also facilitate the detection of emerging or newly emerging zoonotic diseases and new strains of zoonotic organisms.

| (10) | In order to enable further risk assessment under the ‘One Health’ approach and to inform and identify possible risk-management options as regards the risks arising from the circulation of SARS-CoV-2 mink-related variants in animals of the family Mustelidae and in raccoon dogs, an efficient, harmonised monitoring and reporting system allowing for the collection and exchange of all relevant information should be established without delay. |
| --- | --- |

(10)

In order to enable further risk assessment under the ‘One Health’ approach and to inform and identify possible risk-management options as regards the risks arising from the circulation of SARS-CoV-2 mink-related variants in animals of the family Mustelidae and in raccoon dogs, an efficient, harmonised monitoring and reporting system allowing for the collection and exchange of all relevant information should be established without delay.

| (11) | In order to facilitate implementation and to focus resources on higher risk groups, the monitoring system laid down in this act should cover all kept Mustelidae and raccoon dogs, but prioritise establishments with over 500 adult breeders for active monitoring activities and accordingly rules for the sampling and testing for SARS-CoV-2 of animals in those prioritised establishments should be set out in Annex II to this act. In parallel, passive monitoring should be ensured in all kept and wild Mustelidae and raccoon dogs to ensure investigation of specific situations, and accordingly rules for a sampling scheme for the passive monitoring of all such kept or wild animals should be set out in Annex III to this act. |
| --- | --- |

(11)

In order to facilitate implementation and to focus resources on higher risk groups, the monitoring system laid down in this act should cover all kept Mustelidae and raccoon dogs, but prioritise establishments with over 500 adult breeders for active monitoring activities and accordingly rules for the sampling and testing for SARS-CoV-2 of animals in those prioritised establishments should be set out in Annex II to this act. In parallel, passive monitoring should be ensured in all kept and wild Mustelidae and raccoon dogs to ensure investigation of specific situations, and accordingly rules for a sampling scheme for the passive monitoring of all such kept or wild animals should be set out in Annex III to this act.

| (12) | Given the urgency to further assess the risk posed by the epidemiological situation in the Union as regards the occurrence of SARS-CoV-2 in minks and other animals of the family Mustelidae and in raccoon dogs as well as to assess the viability of the measures, Member States should allocate the required resources for setting up a monitoring system and submit to the Commission regular reports on the occurrence of that infection in kept or wild animals of the family Mustelidae and in raccoon dogs. Article 3 of Directive 2003/99/EC provides for the publication of data by the Member States. To ensure proper risk communication within the Union, the Commission should publish on its website, for information only, a summary of the information collected as regards SARS-CoV-2, given the importance of risk communication for that virus. |
| --- | --- |

(12)

Given the urgency to further assess the risk posed by the epidemiological situation in the Union as regards the occurrence of SARS-CoV-2 in minks and other animals of the family Mustelidae and in raccoon dogs as well as to assess the viability of the measures, Member States should allocate the required resources for setting up a monitoring system and submit to the Commission regular reports on the occurrence of that infection in kept or wild animals of the family Mustelidae and in raccoon dogs. Article 3 of Directive 2003/99/EC provides for the publication of data by the Member States. To ensure proper risk communication within the Union, the Commission should publish on its website, for information only, a summary of the information collected as regards SARS-CoV-2, given the importance of risk communication for that virus.

| (13) | To enable reporting, in a structured manner, of occurrences of SARS-CoV-2 in minks and other animals of the family Mustelidae and in raccoon dogs, this Decision should establish the model report, the minimum information requirements and the format for data by outbreak and by species susceptible to the SARS-CoV-2 virus. This model report should be used for reporting purposes for that virus. |
| --- | --- |

(13)

To enable reporting, in a structured manner, of occurrences of SARS-CoV-2 in minks and other animals of the family Mustelidae and in raccoon dogs, this Decision should establish the model report, the minimum information requirements and the format for data by outbreak and by species susceptible to the SARS-CoV-2 virus. This model report should be used for reporting purposes for that virus.

| (14) | Commission Implementing Decision (EU) 2020/2183 (6) lays down rules concerning certain protective measures in relation to reporting infection with SARS-CoV-2 in minks and other animals of the family Mustelidae and in raccoon dogs and applies until 20 April 2021. Implementing Decision (EU) 2020/2183 is based on Article 9(4) of Council Directive 89/662/EEC (7), and on Article 10(4) of Council Directive 90/425/EEC (8). The measures laid down in that Implementing Decision have been shown to be effective and similar measures should be laid down in this Decision. |
| --- | --- |

(14)

Commission Implementing Decision (EU) 2020/2183 (6) lays down rules concerning certain protective measures in relation to reporting infection with SARS-CoV-2 in minks and other animals of the family Mustelidae and in raccoon dogs and applies until 20 April 2021. Implementing Decision (EU) 2020/2183 is based on Article 9(4) of Council Directive 89/662/EEC (7), and on Article 10(4) of Council Directive 90/425/EEC (8). The measures laid down in that Implementing Decision have been shown to be effective and similar measures should be laid down in this Decision.

| (15) | It is urgent to collect the required data for further assessing the risks for human health, for enabling early warning of occurrences of SARS-CoV-2 in minks and other animals of the family Mustelidae and in raccoon dogs, and for monitoring the virus evolution. |
| --- | --- |

(15)

It is urgent to collect the required data for further assessing the risks for human health, for enabling early warning of occurrences of SARS-CoV-2 in minks and other animals of the family Mustelidae and in raccoon dogs, and for monitoring the virus evolution.

| (16) | For disease monitoring purposes, the general principles for calculating the sample size set by the OIE Terrestrial Animal Health Code (9) refer to the need to calculate sample size based on factors such as the size of the population, the design of the survey, the expected prevalence and possible clustering, the level of confidence desired and the performance of the tests used. The EFSA report identifies specific design prevalence percentages for SARS-CoV-2, to achieve a given confidence ratio, which are used to set the design prevalence described in Annex II. These design prevalence and confidence levels directly impact, together with other factors, the expected sample size. These principles should be taken into account in the sampling scheme laid down in this Decision. |
| --- | --- |

(16)

For disease monitoring purposes, the general principles for calculating the sample size set by the OIE Terrestrial Animal Health Code (9) refer to the need to calculate sample size based on factors such as the size of the population, the design of the survey, the expected prevalence and possible clustering, the level of confidence desired and the performance of the tests used. The EFSA report identifies specific design prevalence percentages for SARS-CoV-2, to achieve a given confidence ratio, which are used to set the design prevalence described in Annex II. These design prevalence and confidence levels directly impact, together with other factors, the expected sample size. These principles should be taken into account in the sampling scheme laid down in this Decision.

| (17) | Considering the current epidemiological situation of SARS-CoV-2 in minks and other animals of the family Mustelidae, this Decision should apply until 31 March 2022. In case there are changes in the epidemiological situation, the duration of period of application of this Decision will be reviewed by the Commission. |
| --- | --- |

(17)

Considering the current epidemiological situation of SARS-CoV-2 in minks and other animals of the family Mustelidae, this Decision should apply until 31 March 2022. In case there are changes in the epidemiological situation, the duration of period of application of this Decision will be reviewed by the Commission.

| (18) | Implementing Decision (EU) 2020/2183 should be repealed and replaced by this Decision. |
| --- | --- |

(18)

Implementing Decision (EU) 2020/2183 should be repealed and replaced by this Decision.

| (19) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(19)

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

HAS ADOPTED THIS DECISION:

Article 1

Subject matter and scope

This Decision lays down detailed harmonised rules for the monitoring and reporting by Member States of cases of infection with SARS-CoV-2 in certain animals.

That monitoring and reporting shall cover outbreaks of infection with SARS-CoV-2 in kept and wild animals of the species listed in Annex I (the animals), and shall cover the whole territory of the Member States.

Article 2

Sampling framework for monitoring

Member States shall take the necessary measures to ensure that the competent authorities make appropriate arrangements for:

| (a) | the sampling and testing for SARS-CoV-2 of animals kept in establishments, with more than 500 adult breeders at the beginning of the cycle, in accordance with the sampling scheme set out in Annex II. |
| --- | --- |

(a)

the sampling and testing for SARS-CoV-2 of animals kept in establishments, with more than 500 adult breeders at the beginning of the cycle, in accordance with the sampling scheme set out in Annex II.

| (b) | the sampling and testing for SARS-CoV-2 of kept and wild animals in accordance with the sampling scheme set out in Annex III. |
| --- | --- |

(b)

the sampling and testing for SARS-CoV-2 of kept and wild animals in accordance with the sampling scheme set out in Annex III.

Article 3

Monitoring virus evolution

1.   In the case of detection of the SARS-CoV-2 virus in animals, Member States shall ensure that official laboratories carry out phylogenetic analysis in the presumed index case of each outbreak to characterise the virus.

2.   Member States shall ensure that viruses sequenced from animals in accordance with paragraph 1 are phylogenetically compared to already known sequences and the results of such studies transmitted to the Commission in accordance with Article 4.

Article 4

Reporting

1.   Member States shall submit a report to the Commission within three days from the date of the first confirmation on their territory of the infection of animals with the SARS-CoV-2 virus.

2.   Member States shall submit a follow-up report:

| (a) | on a weekly basis in the case of further outbreaks of new infections with SARS-CoV-2 in animals after the first confirmation referred to in paragraph 1; |
| --- | --- |

(a)

on a weekly basis in the case of further outbreaks of new infections with SARS-CoV-2 in animals after the first confirmation referred to in paragraph 1;

| (b) | when there are relevant updates on the epidemiology of that disease and its zoonotic implications. |
| --- | --- |

(b)

when there are relevant updates on the epidemiology of that disease and its zoonotic implications.

3.   The reports provided for in paragraphs 1 and 2 shall include for each outbreak of SARS-CoV-2 in animals, the information set out in Annex IV.

4.   Where relevant, Member States shall submit a report to the Commission on a monthly basis as regards the results of the phylogenetic analysis and the results of the studies referred to in Article 3.

5.   The reports provided for in paragraphs 1 and 2 shall be communicated in an electronic format to be determined by the Commission in the framework of the Standing Committee on Plants, Animals, Food and Feed.

Article 5

Information by the Commission

1.   The Commission shall inform the Member States in the framework of the Standing Committee on Plants, Animals, Food and Feed of the reports submitted by the Member States in accordance with Article 4.

2.   The Commission shall publish on its website, for information purposes only, an updated summary of the information contained in the reports submitted by the Member States in accordance with Article 4.

Article 6

This Decision shall apply until 31 March 2022.

Article 7

Commission Implementing Decision (EU) 2020/2183 is repealed.

Article 8

This Decision is addressed to the Member States.

Done at Brussels, 12 May 2021.

For the Commission

Stella KYRIAKIDES

Member of the Commission

---

(1)  
  OJ L 325, 12.12.2003, p. 31.

1

(2)  European Centre for Disease Prevention and Control. Detection of new SARS-CoV-2 variants related to mink – 12 November 2020. ECDC: Stockholm; 2020.

2

(3)  https://www.oie.int/fileadmin/Home/MM/GLEWS_risk_assessment_fur_animals_SARS_CoV_2.pdf

3

(4)  EFSA Scientific Report ‘Monitoring of SARS-CoV-2 infection in mustelids’. DOI 10.2903/j.efsa.2021.6459

4

(5)  Guidance on working with farmed animals of species susceptible to infection with SARS-CoV-2, Version 1.2. 16 November 2020. Taken from https://www.oie.int/fileadmin/Home/MM/Draft_OIE_Guidance_farmed_animals_cleanMS05.11.pdf

5

(6)  Commission Implementing Decision (EU) 2020/2183 of 21 December 2020 concerning certain protective measures in relation to reporting infection with SARS-CoV-2 in minks and other animals of the family Mustelidae and in raccoon dogs (OJ L 433, 22.12.2020, p. 76).

6

Mustelidae

(7)  
  OJ L 395, 30.12.1989, p. 13.

7

(8)  
  OJ L 224, 18.8.1990, p. 29.

8

(9)  OIE Terrestrial Animal Health Code (2019 edition); Chapter 1.4. on Animal health surveillance, Article 1.4.4.

9

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ANNEX I

List of animal species subject to monitoring and reporting

| 1. | Minks (Neovison vison) and all other animals belonging to species of the family Mustelidae; |
| --- | --- |

1.

Minks (Neovison vison) and all other animals belonging to species of the family Mustelidae;

| 2. | Raccoon dogs (Nyctereutes procyonoides). |
| --- | --- |

2.

Raccoon dogs (Nyctereutes procyonoides).

---

ANNEX II

Sampling and testing for SARS-CoV-2 of animals kept in establishments, with more than 500 adult breeders at the beginning of the cycle

The competent authority shall ensure that one of the following sampling schemes is followed:

SECTION 1

Default sampling scheme

| (a) | Target population: in each establishment keeping animals, samples shall be taken from every dead and sick animal from each epidemiological unit until the number of animals in the expected sample size is reached; in the absence of dead or sick animals, samples shall also be taken from random live animals to reach the expected sample size. |
| --- | --- |

(a)

Target population: in each establishment keeping animals, samples shall be taken from every dead and sick animal from each epidemiological unit until the number of animals in the expected sample size is reached; in the absence of dead or sick animals, samples shall also be taken from random live animals to reach the expected sample size.

| (b) | Sampling frequency: samples shall be taken weekly. |
| --- | --- |

(b)

Sampling frequency: samples shall be taken weekly.

| (c) | Sample matrix: oropharingeal swabs shall be taken from live or dead animals. |
| --- | --- |

(c)

Sample matrix: oropharingeal swabs shall be taken from live or dead animals.

| (d) | Diagnostic tests: tests shall be taken for the detection of SARS-CoV-2 virus genome. |
| --- | --- |

(d)

Diagnostic tests: tests shall be taken for the detection of SARS-CoV-2 virus genome.

| (e) | Design prevalence to determine the expected sample size: within each establishment, the sample size shall be based on a 5 % prevalence with 95 % confidence. |
| --- | --- |

(e)

Design prevalence to determine the expected sample size: within each establishment, the sample size shall be based on a 5 % prevalence with 95 % confidence.

SECTION 2

First alternative sampling scheme

Based on a positive outcome of a risk assessment, carried out by the competent authority, which considers the sensitivity of alternative sampling methodologies to be equivalent to oropharingeal swabs as referred to in point (c) of Section 1 and the existence of risk mitigating measures for the occurrence of SARS-CoV-2 in the target population in the establishment, the Member States may decide to use the following alternative sampling scheme instead of the default sampling scheme set out in Section 1:

| (a) | Target population: in each establishment keeping animals, samples shall be taken from every dead animal and sick animals as soon as they are identified, from each epidemiological unit until the expected sample size is reached; in the absence of dead or sick animals, samples shall also be taken from random live animals to reach the expected sample size. |
| --- | --- |

(a)

Target population: in each establishment keeping animals, samples shall be taken from every dead animal and sick animals as soon as they are identified, from each epidemiological unit until the expected sample size is reached; in the absence of dead or sick animals, samples shall also be taken from random live animals to reach the expected sample size.

| (b) | Sampling frequency: samples shall be taken every two weeks. |
| --- | --- |

(b)

Sampling frequency: samples shall be taken every two weeks.

| (c) | Sample matrix: oropharingeal swabs shall be taken from dead animals; from live animals either oropharingeal or conjunctival or saliva swabs shall be taken or a combination of such swabs shall be taken; in addition, another option may be added to the swabs matrix, by using expiration air directly collected from all animals by using electronic air collector tools. |
| --- | --- |

(c)

Sample matrix: oropharingeal swabs shall be taken from dead animals; from live animals either oropharingeal or conjunctival or saliva swabs shall be taken or a combination of such swabs shall be taken; in addition, another option may be added to the swabs matrix, by using expiration air directly collected from all animals by using electronic air collector tools.

| (d) | Diagnostic tests: tests for the detection of SARS-CoV-2 virus genome shall be carried out. |
| --- | --- |

(d)

Diagnostic tests: tests for the detection of SARS-CoV-2 virus genome shall be carried out.

| (e) | Design prevalence to determine the expected sample size: within each establishment the sample size shall be based on a 20 % prevalence with 95 % confidence. |
| --- | --- |

(e)

Design prevalence to determine the expected sample size: within each establishment the sample size shall be based on a 20 % prevalence with 95 % confidence.

SECTION 3

Second alternative sampling scheme

Where a risk assessment has been carried out by the competent authority with a positive outcome, and the risk assessment covers the result of SARS-CoV-2 sampling and testing of workers of an establishment and the existence of risk mitigating measures for the occurrence of SARS-CoV-2 in the target population in the establishment, the Member States may decide to rely solely on the sampling scheme for the monitoring of animals provided by Annex III.

---

ANNEX III

Sampling scheme for the monitoring of kept or wild animals

The competent authority shall ensure that the following sampling schemes set out in Section 1 and Section 2 are followed.

SECTION 1

Monitoring in establishments keeping animals

| 1. | The target populations for the sampling shall be the following:






  (a) | In each establishment keeping animals where there is an increased mortality compared to the baseline mortality rate of that specific production period or animals with clinical signs related to SARS-CoV-2: every dead animal or animals with clinical signs related to SARS-CoV-2, from each epidemiological unit until the expected sample size is reached. |
| --- | --- | --- |

1.

(a)

In each establishment keeping animals where there is an increased mortality compared to the baseline mortality rate of that specific production period or animals with clinical signs related to SARS-CoV-2: every dead animal or animals with clinical signs related to SARS-CoV-2, from each epidemiological unit until the expected sample size is reached.

| (b) | In each establishment keeping animals where the competent authority has been informed that cases of SARS-CoV-2 have been detected in the workers of that establishment or their families: every dead animal or animals with clinical signs related to SARS-CoV-2, from each epidemiological unit until the expected sample size is reached. |
| --- | --- |

(b)

In each establishment keeping animals where the competent authority has been informed that cases of SARS-CoV-2 have been detected in the workers of that establishment or their families: every dead animal or animals with clinical signs related to SARS-CoV-2, from each epidemiological unit until the expected sample size is reached.

| 2. | Sampling frequency: sampling shall be carried out every time an animal suspected of being infected with SARS-CoV-2 is identified as indicated in the target population referred to in point 1. |
| --- | --- |

2.

| 3. | Sample matrix: oropharingeal swabs shall be taken from dead or live animals referred to in point 1. |
| --- | --- |

3.

| 4. | Diagnostic tests: tests for the detection of SARS-CoV-2 virus genome shall be carried out. |
| --- | --- |

4.

| 5. | Design prevalence to determine the expected sample size for the target population referred to in:






  (i) | point (1)(a): within each establishment, the sample size shall be based on a 50 % prevalence with 95 % confidence; |
| --- | --- | --- |

5.

(i)

point (1)(a): within each establishment, the sample size shall be based on a 50 % prevalence with 95 % confidence;

| (ii) | point (1)(b): within each establishment, the sample size shall be based on a 5 % prevalence with 95 % confidence. |
| --- | --- |

(ii)

point (1)(b): within each establishment, the sample size shall be based on a 5 % prevalence with 95 % confidence.

SECTION 2

Monitoring in all other kept or wild animals

| 1. | The target populations for the sampling shall be for all other kept or wild animals excluding those kept in establishments: animal suspected of being infected with SARS-CoV-2 which have died, or were found dead, or animals with clinical signs related to SARS-CoV-2. |
| --- | --- |

1.

| 2. | Sampling frequency: sampling shall be carried out every time an animal suspected of being infected with SARS-CoV-2 is identified as indicated in the target population referred to in point 1. |
| --- | --- |

2.

| 3. | Sample matrix: oropharingeal swabs shall be taken from dead or live animals referred to in point 1. |
| --- | --- |

3.

| 4. | Diagnostic tests: tests for the detection of SARS-CoV-2 virus genome shall be carried out. |
| --- | --- |

4.

| 5. | Design prevalence to determine the expected sample size: sampling of all reported animals that have died, or were found dead, or animals with clinical signs related to SARS-CoV-2; in case more than 5 animals were found dead in the same place or presumed to belong to the same epidemiological unit, the sample size shall be limited to 5 randomly selected animals. |
| --- | --- |

5.

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ANNEX IV

Information to be contained in the reports provided for in Article 4 in relation to outbreaks of infection with SARS-CoV-2 in animals (‘susceptible species’)

| 1. | Date of reporting; |
| --- | --- |

1.

Date of reporting;

| 2. | Member State; |
| --- | --- |

2.

Member State;

| 3. | Type of report (first confirmation report/weekly-follow-up report); |
| --- | --- |

3.

Type of report (first confirmation report/weekly-follow-up report);

| 4. | Total number of outbreaks in the Member State included in the report; |
| --- | --- |

4.

Total number of outbreaks in the Member State included in the report;

| 5. | For each outbreak provide:






  (a) | Serial number of each outbreak in the Member State; |
| --- | --- | --- |

5.

For each outbreak provide:

(a)

Serial number of each outbreak in the Member State;

| (b) | Region and approximate geographical location of the establishment or other place where animals were kept or located; |
| --- | --- |

(b)

Region and approximate geographical location of the establishment or other place where animals were kept or located;

| (c) | Date of suspicion; |
| --- | --- |

(c)

Date of suspicion;

| (d) | Date of confirmation; |
| --- | --- |

(d)

Date of confirmation;

| (e) | Diagnostic method(s); |
| --- | --- |

(e)

Diagnostic method(s);

| (f) | Date of estimation of introduction of the virus in the establishment or place; |
| --- | --- |

(f)

Date of estimation of introduction of the virus in the establishment or place;

| (g) | Possible source of the virus; |
| --- | --- |

(g)

Possible source of the virus;

| (h) | Control measures taken (details (1)); |
| --- | --- |

(h)

Control measures taken (details (1));

| (i) | Number of susceptible animals on establishment or at the place (by susceptible species); |
| --- | --- |

(i)

Number of susceptible animals on establishment or at the place (by susceptible species);

| (j) | Number of animals clinically or subclinically affected on establishment or at the place (by susceptible species; in case an exact figure is not available, an estimate must be provided); |
| --- | --- |

(j)

Number of animals clinically or subclinically affected on establishment or at the place (by susceptible species; in case an exact figure is not available, an estimate must be provided);

| (k) | Morbidity: number of animals (by susceptible species) clinically affected, with signs resembling COVID-19, on establishment or at the place in relation to the number of susceptible animals with a summary description of the clinical signs (in case an exact figure is not available, an estimate must be provided); |
| --- | --- |

(k)

Morbidity: number of animals (by susceptible species) clinically affected, with signs resembling COVID-19, on establishment or at the place in relation to the number of susceptible animals with a summary description of the clinical signs (in case an exact figure is not available, an estimate must be provided);

| (l) | Mortality: number of animals (by susceptible species) that have died on establishment or at the place (in case an exact figure is not available, an estimate must be provided); |
| --- | --- |

(l)

Mortality: number of animals (by susceptible species) that have died on establishment or at the place (in case an exact figure is not available, an estimate must be provided);

| 6. | Data on molecular epidemiology, significant mutations; |
| --- | --- |

6.

Data on molecular epidemiology, significant mutations;

| 7. | Where relevant, non-personal epidemiological data on human cases in the Member State directly related to animal outbreaks referred to in Article 4(1) and (2); |
| --- | --- |

7.

Where relevant, non-personal epidemiological data on human cases in the Member State directly related to animal outbreaks referred to in Article 4(1) and (2);

| 8. | Other relevant information. |
| --- | --- |

8.

Other relevant information.

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(1)  Movement control inside the Member State; surveillance within containment or protection zone; traceability; quarantine; official disposal of carcasses, by-products and waste; stamping out; control of wildlife reservoirs; zoning; disinfection; vaccination of animals permitted (if a vaccine exists); no treatment of affected animals and other relevant measures.

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| 17.5.2021 | EN | Official Journal of the European Union | L 173/15 |
| --- | --- | --- | --- |

17.5.2021

EN

Official Journal of the European Union

L 173/15

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DECISION (EU) 2021/789 OF THE SINGLE RESOLUTION BOARD

of 31 March 2021

on discharge in respect of the implementation of the budget and on the closure of the accounts of the Single Resolution Board (‘SRB’) for the financial year 2019 (SRB/PS/2021/03)

THE SINGLE RESOLUTION BOARD,

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

Having regard to Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 (1), and in particular, Articles 50(1)(b) and 63(8) of the SRM Regulation,

Having regard to Article 97, 98 and 99 of the SRB Financial Regulation of 17 January 2020,

Having regard to the Final Annual Accounts of the SRB for the financial year 2019 as adopted on 24 June 2020 (the ‘2019 Final Annual Accounts’),

Having regard to the Annual Report of the SRB for the financial year 2019 as adopted on 20 May 2020 by way of a written procedure (the ‘2019 Annual Report’),

Having regard to the European Court of Auditors’ Report on the annual accounts of the Single Resolution Board (SRB) for the financial year 2019, together with the SRB’s replies (the ‘2019 Court of Auditors’ Annual Report’),

Having regard to the Report on the 2019 Final Annual Accounts including audit opinions dated 15 June 2020 prepared by Mazars Réviseurs d’Enterprises (the ‘Mazars 2019 Audit Report’),

Having regard to the European Court of Auditors’ Report (pursuant to Article 92(4) of Regulation (EU) No 806/2014) on any contingent liabilities arising as a result of the performance by the Single Resolution Board, the Council or the Commission of their tasks under the SRM Regulation for the financial year 2019 (the ‘Court of Auditors’ Contingent Liabilities Report 2019’),

Having regard to the Internal Audit Annual Report 2019 dated 19 December 2019 presented to and noted by the Board in its Plenary Session on 29 January 2020 (the ‘Internal Audit Annual Report 2019’),

HAS ADOPTED THIS DECISION:

| 1. | Grant the Chair of the SRB discharge in respect of the implementation of the SRB’s budget for the financial year 2019; |
| --- | --- |

1.

| 2. | Approve the closure of the accounts of the SRB for the financial year 2019; |
| --- | --- |

2.

| 3. | Set out its observations in the motion below; |
| --- | --- |

3.

| 4. | Instruct the Chair of the Single Resolution Board to notify this Decision to the Council, the Commission and the Court of Auditors, to arrange for its publication in the Official Journal of the European Union (L series), and on the website of the SRB. |
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4.

For the Single Resolution Board,

Dr Thorsten PÖTZSCH

Plenary Member

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(1)  
  OJ L 225, 30.7.2014, p. 1.

1

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