(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).

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(19)

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