Infokiri

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5. Infection with Mycobacterium tuberculosis complex (focusing on 1 Mycobacterium bovis and Mycobacterium caprae) 2

3

The summary data which make up this chapter, as well as additional information on related projects 4 and internet sources, are published for this report on the EFSA Knowledge Junction at Zenodo here. 5 Summary statistics on human surveillance data with downloadable files are retrievable using the ECDC 6 Surveillance Atlas of Infectious Diseases available here. 7

For additional information about zoonotic tuberculosis focusing on Mycobacterium bovis and M. caprae 8 and for the consultation of data collected, the following interactive tools are available: 9

10 11

5.1. Key facts 12

 In 2023, the percentage of zoonotic tuberculosis cases in humans out of total number of 13 tuberculosis cases in humans in the EU/EEA countries was 0.35%. There were 138 confirmed 14 cases of human tuberculosis due to Mycobacterium bovis or Mycobacterium caprae, 15 corresponding to an EU notification rate of 0.04 cases per 100,000 population. This resulted in 16 a notification decrease in the EU of 6.1% compared with 2022. 17

 In 2023 and 2022, the number of cases of human tuberculosis due to M. bovis or M. caprae in 18 the EU remained higher than during the pandemic years 2020 and 2021. In 2023, the number 19 of human cases among the 25 MSs exceeded the number of cases reported in 2019. 20

 In 2023, the M. bovis and M. caprae case notification rate was 0.03 cases per 100,000 among 21 EU MSs with disease-free status and 0.05 cases per 100,000 in EU MSs with non-disease-free 22 status for the bovine population. 23

 The majority of M. bovis and M. caprae cases in humans (48.6%) were of EU origin (native 24 cases and/or cases originating from other MSs). 25

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 In bovine animals, in 2023, the overall prevalence of tuberculosis (0.57%) due to M. bovis or 26 M. caprae decreased slightly compared with the previous year (0.61%), and the number of 27 infected cattle herds in the European Union decreased from 9845 to 8821 herds. 28

 Similar to previous years, the distribution of infected herds was heterogeneous and spatially 29 clustered, with a national herd-level prevalence ranging from <0.01% (Austria, Germany, 30 Poland, Romania) to 7.2% (the United Kingdom (Northern Ireland). 31

 Seventeen Member States had the disease-free status in 2023. Ten Member States, along with 32 the United Kingdom (Northern Ireland), were under an eradication programme, of which three 33 Member States (Italy, Portugal and Spain) had disease-free status zones. 34

 In the disease-free status zones, a total of 162 cattle herds (0.02%) were reported to be 35 infected with the Mycobacterium tuberculosis complex, 13 more compared to 2022, confirming 36 that infection occurs rarely in these areas. 37

 In the zones under an eradication programme 8659 cattle herds (1.5% of the total) tested 38 positive for Mycobacterium tuberculosis complex in 2023, a 10.7% decrease from 9,696 herds 39 in 2022. The United Kingdom (Northern Ireland) (7.2%), Ireland (4.8%) and Spain (3.2%) were 40 the only countries with a prevalence higher than 1%. No positive herds were reported by 41 Bulgaria, Cyprus or Malta. Over the last decade (2014–2023), the total number of positive cattle 42 herds in UEP zones decreased by 49.4%, largely due to the withdrawal of the United Kingdom 43 from the EU in 2020. 44 45

5.2. Surveillance and monitoring of tuberculosis due to Mycobacterium 46 bovis or Mycobacterium caprae in the EU 47

5.2.1. Humans 48

The notification of tuberculosis in humans is mandatory in all MSs and covers the whole population. 49 Countries can update their data retroactively; reported numbers are therefore subject to change in the 50 future or may vary from numbers reported in previous reports. The M. bovis and M. caprae EU 51 notification rate is calculated using the combined population of the EU MSs that reported data in 2023. 52 The proportion of tuberculosis cases caused by M. bovis or M. caprae was calculated using the 53 preliminary estimate of the total number of confirmed tuberculosis cases in 2023 among reporting EU 54 MSs’ species-specific data. In 2023, no human data on M. bovis or M. caprae cases were available for 55 France because this MS did not report species-specific data within the M. tuberculosis complex (MTBC) 56 for human tuberculosis cases. France has not reported species-specific data in any previous years. In 57 addition, Latvia did not report any MTBC data for 2019, 2020, and 2023. 58

Because tuberculosis is a chronic disease with a long incubation period, it is not possible to assess 59 travel-associated cases in the same way as for diseases with acute onset. Instead, a distinction is made 60 between individuals with the disease originating from an EU MS (cases of EU origin) and those 61 originating from outside the EU (case originating outside of the EU). In the analysis, origin is mainly 62 based on the reported birthplace, except for cases from Austria, Belgium, Greece, Hungary and Poland, 63 whose origin is based on reported nationality. 64

5.2.2. Animals 65

Bovine tuberculosis surveillance data 66

Article 2 of Regulation (EU) 2016/429 (the new ‘Animal Health Law’ – AHL) states that its scope 67 applies to transmissible diseases, including zoonoses, without prejudice to the provisions laid down in 68 Directive 2003/99/EC (i.e. the Zoonoses Directive). Therefore, the annual zoonoses data reporting 69 requirements for MSs, as stipulated in Directive 2003/99/EC and implemented by EFSA through specific 70 tools, manuals and guidance, remain unaffected by the entry into force of Commission Implementing 71 Regulation (CIR) (EU) 2020/20021. This latter CIR outlines the compulsory notification and annual 72

1 Commission Implementing Regulation (EU) 2020/2002 of 7 December 2020 laying down rules for the application of Regulation

(EU) 2016/429 of the European Parliament and of the Council with regard to Union notification and Union reporting of listed diseases, to formats and procedures for submission and reporting of Union surveillance programmes and of eradication programmes and for application for recognition of disease-free status, and to the computerised information system, OJ L 412, 8.12.2020, p. 1–28

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reporting obligations that MSs must fulfil with respect to ADIS2: EU MSs need to report to ADIS 73 outbreaks of infection with MTBC in bovine species (cattle, buffalo and bison), even-toed ungulates 74 (Artiodactyla) and other terrestrial mammals. Summaries of these reports are regularly made available 75 online. 76

In accordance with the Zoonoses Directive, MSs must report annual surveillance data for bovine 77 tuberculosis. These data are derived from compulsory national eradication and surveillance programmes 78 implemented in compliance with EU legislation, including the AHL. The reports submitted by MSs are 79 harmonised and enable the assessment of the epidemiological situation and trends analysis across MSs 80 and their zones. 81

Article 36 of Regulation (EU) 2016/429 provides for the European Commission’s approval of the 82 disease-free status (DFS) of MSs or specific zones within them, with respect to MTBC infections. Due to 83 the differing levels of infection risk between DFS zones and zones under an eradication programme 84 (UEP), these zones have been treated separately in this chapter. 85

All cases of bovine tuberculosis caused by the MTBC members (M. bovis, M. caprae or M. 86 tuberculosis) were considered in summarising the EU situation on the disease in cattle. Whenever 87 possible, reporting MSs provided detailed distinctions between these MTBC species. 88

Mycobacterium surveillance data from food and from animals other than bovine animals 89

Mycobacterium spp. monitoring data from food and from animals other than bovine animals are 90 submitted to EFSA in accordance with Directive 2003/99/EC. Data collected allow for descriptive 91 summaries to be compiled at the EU level, but do not allow trend watching or trend analyses (Error! 92 Reference source not found.). 93

In accordance with CIR (EU) 2020/2002, notification to ADIS and surveillance rules apply to other 94 Artiodactyla than bovine animals (such as camelids, cervids, suidae, ovine and caprine animals) and 95 other terrestrial mammals susceptible to infection with MTBC. 96

5.3. Results 97

5.3.1. Overview of key statistics, EU, 2019–2023 98

Error! Reference source not found.summarises the EU-level statistics on human tuberculosis due 99 to M. bovis or M. caprae and on bovine tuberculosis during 2019–2023. More detailed descriptions of 100 these statistics are provided in the subsections below. 101

Table 38: Summary of tuberculosis due to Mycobacterium bovis and 102 Mycobacterium caprae statistics relating to humans and bovine animals 103 (stratified by disease status of MSs/ MS zones), EU, 2019–2023. 104

2023a 2022a 2021a 2020 2019b Data

source

Humans

Number of confirmed M. bovis cases 129 140 108 95 141 ECDC

Number of confirmed M. caprae cases 9 7 10 4 11 ECDC

Total number of confirmed cases 138 147 118 99 152 ECDC

Total number of confirmed cases/100,000 population (notification rates) 0.04 0.04 0.03 0.03 0.03 ECDC

Number of EU MSs that reported data on M. bovis or M. caprae cases

25 26 26 25 26 ECDC

M. bovis or M. caprae cases in individuals of EU origin

67 93 63 60 107 ECDC

M. bovis or M. caprae cases in individuals originating from outside EU 62 47 49 35 40 ECDC

M. bovis or M. caprae cases in individuals of unknown origin

9 7 6 4 5 ECDC

2 EU Animal Diseases Information System (ADIS). More information is available at: https://food.ec.europa.eu/animals/animal-

diseases/animal-disease-information-system-adis_en

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Total number of foodborne outbreaksc 1 0 0 0 0 EFSA

Number of outbreak-related cases 3 0 0 0 0 EFSA

Bovine animals

Number of infected herds in disease-free status zonesd

162 149 139 139 143 EFSA

Number of reporting disease-free status MSsd 17 17 17 17 17 EFSA

Number of infected herds in zones under an eradication programmee

8,659 9,696 9,255 7,233 16,277 EFSA

Number of reporting MSs with zones under an eradication programmee

11 11 11 9f 11 EFSA

Abbreviations: ECDC, European Centre for Disease Prevention and Control; EFSA, European Food Safety Authority; MSs, Member 105 States. 106

aData from the United Kingdom (Northern Ireland) were taken into account for 2021–2023. In accordance with the Agreement 107 on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European 108 Atomic Energy Community, and in particular Article 5(4) of the Windsor Framework (see Joint Declaration No 1/2023 of the 109 Union and the United Kingdom in the Joint Committee established by the Agreement on the withdrawal of the United Kingdom 110 of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community of 24 March 2023, 111 OJ L 102, 17.4.2023, p.87) in conjunction with section 24 of Annex 2 to that Framework, for the purposes of this Regulation, 112 references to Member States include the United Kingdom in respect of Northern Ireland. 113

bData from the United Kingdom were taken into account for the 2018–2019 period, since the United Kingdom was still an EU MS 114 at that time. However, on 1 February 2020 it became a third country. 115

cNo information on the species was available for the Mycobacterium outbreak reported in 2023 116 dMember States, or zones thereof, with disease-free status regarding infection with the Mycobacterium tuberculosis complex (M. 117

bovis, M. caprae, M. tuberculosis (MTBC) in their bovine animal population. 118 eThe Member States or zones thereof with an approved eradication programme (UEP) for infection with MTBC. In addition, the 119

United Kingdom (Northern Ireland) has an approved eradication programme for infection with MTBC. 120 fNo data reported from Bulgaria. 121

5.3.2. Tuberculosis due to Mycobacterium bovis or Mycobacterium caprae in 122 humans 123

In 2023, 138 confirmed human cases of tuberculosis due to M. bovis or M. caprae were reported from 124 13 MSs (Austria, Belgium, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Netherlands, 125 Romania, Spain and Sweden) (Table 39: ). Tuberculosis cases due to M. bovis (129 cases) were reported 126 from all the above mentioned MSs except Hungary, which only reported cases caused by M. caprae. 127 Austria, Germany and Spain also reported cases due to M. caprae, which accounted altogether for 9 128 cases in the EU. 129

In 2023, tuberculosis cases due to M. bovis or M. caprae accounted for a small proportion (0.35%) of 130 total tuberculosis cases reported in the EU, Iceland, Norway, Liechtenstein and Switzerland. Overall, 25 131 MSs reported species-specific data on MTBC while twelve MSs did not report any cases. Reported cases 132 of human tuberculosis due to M. bovis or M. caprae in the EU slightly decreased in 2023 compared to 133 2022 but remained high when compared to the 2020-2021 COVID-19 pandemic years. 134

The EU notification rate in 2023 was 0.036 cases per 100,000 population, which was a decrease of 6.1% 135 compared with 2022, when the notification rate was 0.039 per 100,000 population. In 2023, the highest 136 notification rate was reported by Ireland (0.15 per 100,000), followed by Spain (0.11 per 100,000). 137

Among the 17 MSs with disease-free status (DFS) in 2023, 15 MSs reported on MTBC species. M. bovis 138 and M. caprae human cases were reported in eight MSs. The notification rate in these MSs reporting on 139 MTBC species was 0.03 cases per 100,000 population. The notification rate for M. bovis and M. caprae 140 human cases reported in the 10 non-DFS MSs in 2023 was 0.05 cases per 100,000 population. 141

The majority of the M. bovis and M. caprae human cases reported in 2023 (67/138; 48.6%) were of EU 142 origin (native cases and/or cases originating from other MSs). The other cases originated from outside 143 the EU (N = 62; 44.9%) or had unknown origin (N = 9; 6.5%) (Table 38: ). Notification rates of M. bovis 144 and M. caprae human cases of EU origin were lower in disease-free MSs (N = 26; 38.8%) than in non-145 disease-free MSs (N = 41; 61.2%). 146

Table 39: Reported confirmed human cases of tuberculosis due to Mycobacterium bovis or 147 Mycobacterium caprae and notification rates per 100,000 population in EU MS and non-MS countries, 148 by country and year, 2019–2023. 149

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Country

2023 2022 2021 2020 2019

Status National

coveragea Data

formata

Confirmed cases and

rates

Confirmed cases and

rates

Confirmed cases and

rates

Confirmed cases and

rates

Confirmed cases and

rates Cases Rate Cases Rate Cases Rate Cases Rate Cases Rate

Austria DFS Y C 3 0.03 5 0.06 4 0.04 0 0 3 0.03 Belgium DFS Y C 3 0.03 9 0.08 10 0.09 6 0.05 0 0 Bulgaria Y C 0 0 0 0 0 0 0 0 0 0 Croatia Y C 0 0 0 0 0 0 0 0 0 0 Cyprus Y C 0 0 0 0 0 0 0 0 0 0 Czechia DFS Y C 0 0 0 0 0 0 0 0 0 0 Denmark DFS Y C 1 0.02 0 0 0 0 0 0 0 0 Estonia DFS Y C 0 0 0 0 0 0 0 0 0 0 Finland DFS Y C 1 0.02 0 0 0 0 1 0.02 0 0 Franceb DFS – – – – – – – – – – – – Germany DFS Y C 48 0.06 38 0.05 44 0.05 37 0.04 51 0.06 Greece Y C 1 0.01 1 0.01 0 0 2 0.02 1 0.01 Hungary DFS Y C 1 0.01 0 0 0 0 0 0 0 0 Ireland Y C 8 0.15 7 0.14 2 0.04 4 0.08 7 0.14 Italy Y C 8 0.01 15 0.03 12 0.02 6 0.01 11 0.02 Latviac DFS Y C – – 0 0 0 0 – – – – Lithuania DFS Y C 0 0 0 0 0 0 0 0 0 0 Luxembourg DFS Y C 0 0 0 0 0 0 0 0 0 0 Malta Y C 0 0 0 0 0 0 0 0 0 0 Netherlands DFS Y C 6 0.03 5 0.03 5 0.03 6 0.03 5 0.03

Poland DFS Y C 0 0 1 < 0.01 0 0 0 0 0 0

Portugal Y C 0 0 0 0 0 0 0 0 0 0 Romania Y C 3 0.02 1 0.01 0 0 1 0.01 1 0.01 Slovakia DFS Y C 0 0 0 0 0 0 0 0 0 0 Slovenia DFS Y C 0 0 0 0 0 0 0 0 0 0 Spain Y C 54 0.11 59 0.12 37 0.08 30 0.06 35 0.07 Sweden DFS Y C 1 0.01 6 0.06 4 0.04 6 0.06 3 0.03

EU Total 27 138 0.04 147 0.04 118 0.03 99 0.03 117 0.03 United Kingdom

– – – – – – – – – – 35 0.05

EU Total 138 0.04 147 0.04 118 0.03 99 0.03 152 0.03

Icelandd Y C 0 0 0 0 0 0 0 0 0 0 Norway DFS Y C 1 0.02 0 0 0 0 0 0 1 0.02 Liechtenstein DFS Y C 0 0 0 0 0 0

3 0.03 4 0.05 Switzerlande DFS Y C 10 0.11 1 0.01 4 0.05

Abbreviations: –, Data not reported; DFS, Disease-free status, i.e. free of infection with M. bovis, M. caprae or M. tuberculosis in 150 the bovine animal population. 151 aY: yes; N: no; A: aggregated data; C: case-based data. 152 bNo surveillance system. 153 cLatvia did not report any MTBC data during 2019–2020 and 2023 154 dIn Iceland, which has no special agreement concerning animal health (status) with the EU, the last outbreak of bovine tuberculosis 155 was in 1959. 156 eSwitzerland provided data directly to EFSA. The human data for Switzerland include data from Liechtenstein for the years 2019–157 2020. 158

159

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Figure 10 shows, for year 2023, the number of confirmed tuberculosis cases due to M. bovis or M. 160 caprae in individuals of EU origin overlaid with the national aggregated herd prevalence of bovine 161 tuberculosis. 162

163 Member States that reported data at the national level without specifying the specific zones or overseas territories where the 164 bovine tuberculosis-positive cattle herds were detected, were assigned the same color for all their zones, including overseas 165 territories. For Albania, Kosovo and Serbia, prevalence data refer to animal tested. 166

Map of the number of confirmed tuberculosis cases due to Mycobacterium bovis or 167 Mycobacterium caprae in individuals of EU origin, and national herd prevalence of tuberculosis in the 168 bovine animal population in EU MS and non-MS countries, 2023 169

5.3.3. Mycobacterium in food 170

No Mycobacterium species monitoring data from food were submitted for the year 2023. 171

5.3.4. Tuberculosis in bovine animals 172

Bovine tuberculosis surveillance data 173

Seventeen MSs had DFS regarding MTBC during 2023 (Error! Reference source not found.). Of the 174 remaining 10 MSs and the United Kingdom (Northern Ireland), three MSs had DFS zones or provinces: 175

- Italy: 12 regions and 23 provinces; 176 - Portugal: two regions (Algarve and Azores, except the island of São Miguel); 177 - Spain: seven autonomous communities and three provinces. 178

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Seven MSs had no zones with DFS regarding MTBC. The United Kingdom (Northern Ireland) had no DFS 179 zones either. 180 Norway, Switzerland and Liechtenstein had DFS, in accordance with the EU legislation. In Iceland, which 181 has no special agreement with the EU on animal health status, the last outbreak of bovine tuberculosis 182 was reported in 1959. A map of EU MSs’ disease status is available at link here. 183 In 2023, the overall proportion of cattle herds in the EU infected with MTBC was very low, 0.57%, a 184 slight decrease from 0.61% in 2022. The total number of infected bovine herds in the EU also decreased, 185 from 9845 in 2022 to 8821 in 2023. 186 Fifteen MSs (12 DFS and three UEP countries) reported no cases of bovine tuberculosis. The remaining 187 12 MSs and the United Kingdom (Northern Ireland) reported cases of bovine tuberculosis, with 188 prevalence varying widely at the national level. MTBC infections were primarily concentrated in UEP 189 zones, where the overall prevalence of infected herds (1.5%) was 85 times higher than in DFS zones 190 (0.02%). 191 Five MSs reported MTBC infections in cattle without specifying the Mycobacterium species. M. bovis was 192 specifically detected in France, Germany, Ireland, Italy, Poland, Romania and the United Kingdom 193 (Northern Ireland), while M. caprae was specifically reported in Austria, Germany and Romania. No 194 cases of M. tuberculosis infection in cattle herds were reported. 195

MSs and MSs’ zones with disease-free status regarding Mycobacterium tuberculosis 196 complex infection 197

The majority of the EU’s cattle herd population (61.4%) is located in the DFS zones across 20 MSs. 198 However, the number of cattle herds in these zones has steadily declined, with a 27.6% decrease over 199 the last decade (2014–2023). Over this 10-year period there was a slight increase in both the number 200 of infected herds and the prevalence of MTBC-infected herds (Figure 11: ). 201

Seven MSs with DFS zones reported a total of 162 MTBC-infected bovine herds, confirming that the 202 detection of bovine tuberculosis in DFS zones is rare. When comparing 2023 to 2022, the number of 203 infected cattle herds increased by 13, while the prevalence remained unchanged at 0.02%. The total 204 number of cattle herds decreased by 2.9%. 205

206

207 (*): In contrast to years 2014–2019, the year 2020 does not include the United Kingdom (Scotland) data. Since 1 February 2020, 208

the United Kingdom has withdrawn from the EU and has become a third country. 209

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Prevalence of cattle herds infected with the Mycobacterium tuberculosis complex in 210 disease-free status (DFS) zones, EU, 2014–2023 211

MSs and MSs’ zones with an approved eradication programme for infection with 212 Mycobacterium tuberculosis complex 213

In 2023, cattle herds from UEP zones across 10 MSs and the United Kingdom (Northern Ireland) 214 represented 38.6% of the total EU cattle herd population. This population has been steadily declining, 215 with a 51.0% decrease compared to 2014 (Figure 12: ). Over the last decade (2014–2023), the 216 prevalence of bovine tuberculosis in UEP zones has shown varying trends. From 2014 to 2019, data 217 included the EU-28 MSs. However, the sharp decrease in 2020 can be attributed to the withdrawal of 218 the United Kingdom from the EU and to the absence of data from Bulgaria in that year. Starting from 219 2021, the increase in the number of reported cattle herds can be mainly explained by the resumption 220 of data from Bulgaria after its 2020 hiatus and by the inclusion of data from the United Kingdom 221 (Northern Ireland)3. Over the last decade (2014–2023), the total number of positive cattle herds in UEP 222 zones decreased by 49.4%, whereas the prevalence increased by 3.1%. 223 Seven Member States and the United Kingdom (Northern Ireland) reported a total of 8659 herds positive 224 for bovine tuberculosis in 2023, a 10.7% decrease from 9,696 herds in 2022. This reduction was 225 primarily driven by the United Kingdom (Northern Ireland), which had reported 2,785 (12.2%) MTBC-226 positive herds in 2022. The United Kingdom (Northern Ireland) (7.2%), Ireland (4.8%) and Spain 227 (3.2%) were the only countries with a prevalence higher than 1%. No positive herds were reported by 228 Bulgaria, Cyprus or Malta. Compared with 2022, the overall prevalence in UEP zones remained stable 229 at around 1.5%. 230 231 232

3 Data from the United Kingdom (Northern Ireland) were taken into account for 2021–2023. In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Windsor Framework (see Joint Declaration No 1/2023 of the Union and the United Kingdom in the Joint Committee established by 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 of 24 March 2023, OJ L 102, 17.4.2023, p.87) in conjunction with section 24 of Annex 2 to that Framework, for the purposes of this Regulation, references to Member States include the United Kingdom in respect of Northern Ireland

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233 * In contrast to years 2014–2019, year 2020 does not include the United Kingdom data. Since 1 February 2020, the United 234 Kingdom has withdrawn from the EU and has become a third country. No 2020 data were reported from Bulgaria. 235 ** Data from the United Kingdom (Northern Ireland) were taken into account for 2021–2023. In accordance with the Agreement 236

on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European 237 Atomic Energy Community, and in particular Article 5(4) of the Windsor Framework (see Joint Declaration No 1/2023 of the 238 Union and the United Kingdom in the Joint Committee established by the Agreement on the withdrawal of the United Kingdom 239 of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community of 24 March 2023, 240 OJ L 102, 17.4.2023, p.87) in conjunction with Section 24 of Annex 2 to that Framework, for the purposes of this Regulation, 241 references to MSs include the United Kingdom in respect of Northern Ireland. 242

Prevalence of cattle herds positive for bovine tuberculosis in zones under an eradication 243 programme (UEP), EU, 2014–2023 244

Non-Member States and pre-accession countries 245

Bovine tuberculosis was not detected in 2023 in Iceland, Liechtenstein or Switzerland, whereas Norway 246 reported one infected cattle herd and a herd prevalence of 0.01%. Among the pre-accession countries, 247 Montenegro, as in the previous 3 years, reported no infected herds; the Republic of North Macedonia 248 reported a herd prevalence of 0.08% (10/12,621), whereas Albania reported a prevalence of 0.01% 249 (7/94,252). Kosovo4 reported a prevalence of 0.07% intradermal tuberculin skin test-positive bovines 250 (17/25,000)5. 251

5.3.5. Mycobacterium tuberculosis complex surveillance data from animals other 252 than bovine animals 253

In 2023, two MSs (Finland, Sweden), the United Kingdom (Northern Ireland) and one non-MS (Norway) 254 reported surveillance data on infection in farmed deer. In particular, Sweden reported data from a 255 control programme in farmed deer. One case of MTBC infection in farmed deer was reported by the 256 United Kingdom (Northern Ireland). 257

MSs also reported cases of MTBC infection in other mammal species. In particular, M. bovis was detected 258 in farmed alpacas (Ireland), goats (France, Ireland), pigs (France, Ireland, Italy, the United Kingdom 259

4 This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence. 5 The prevalence reported by Kosovo in 2022 was 3.1% (78/2,500).

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(Northern Ireland)), cats (France, Switzerland, the United Kingdom (Northern Ireland)), wild deer (Italy, 260 Ireland), wild boar (Spain, France, Italy) and badgers (France, Ireland, the United Kingdom (Northern 261 Ireland)). M. caprae was detected in laboratory monkeys (France). Finally, M. tuberculosis was detected 262 in an African elephant (zoo animal) in Switzerland. 263 264 Refer to the dashboard mentioned at the beginning of the chapter for detailed insights. 265

5.4. Discussion 266

In 2023, the reporting of human tuberculosis due to M. bovis and M. caprae resulted in a total of 267 138 cases, a decrease compared with year 2022. This corresponded in a relative notification decrease 268 of 6.1% in 2023 (0.036 cases per 100,000) compared with 2022 (0.039 per 100,000 population). In 269 particular, the decrease was due to M. bovis cases, by far the most frequent infection compared to M. 270 caprae cases. Total cases of M. caprae appear to be relatively constant over the years. It is important 271 to highlight that analysing the last 5 years trend, notification cases are still higher in 2022-2023 than in 272 the previous 3 years, but this fact is mainly due to the increased number of cases in Spain. Taken all 273 together, in the other countries a relatively stable epidemiological situation was observed during the 274 long period, suggesting the normalization of the effect of the COVID-19 pandemic on human cases. 275

The specific analysis by countries showed that 12 MSs reported no cases. In addition, notification of 276 total cases noticeably decreased in Austria, Belgium, Italy, Spain and Sweden. In contrast, some 277 countries showed an increase of total cases, particularly Germany. As expected, the total number of 278 cases were highest in Germany and Spain but when the data were referred to the human population, 279 the highest notification rates were observed for Ireland and Spain, i.e. both countries with no disease 280 free status for tuberculosis in bovine population demonstrating the importance of reaching a full disease-281 free status. The number of notifications clearly depends on efficient surveillance standards and rapid 282 diagnostic intervention. Finally, France and Latvia did not report any MTBC data in 2023. When checking 283 the native versus foreigner's ratio, for the first year the number approaches to 1, with native total 284 notification numbers being constant over the recent years, whereas foreigner cases tend to increase, 285 likely because of the resumption of the population movement after the COVID-19 pandemic restrictions. 286

Tuberculosis cases of zoonotic origin (due to M. bovis or M. caprae) and notification rates are highly 287 likely to have been underestimated. Bias is introduced by those EU MSs that do not regularly perform 288 routine tests to distinguish M. bovis and M. caprae from M. tuberculosis, resulting in under-notification 289 at the EU level, because all cases in those MSs are reported as M. tuberculosis, and undermining the 290 possibility of tracing the origin of infections (Fujiwara and Olea-Popelka, 2016). Furthermore, a lower 291 notification rate was observed in EU MSs with DFS compared with non-DFS MSs, supporting the 292 effectiveness of the surveillance programmes. 293

In conclusion, despite a general alarm that occupational exposure to zoonotic tuberculosis is an 294 underestimated threat, in particular in developing countries (Devi, Lee, et al, 2021), EU 2023 human 295 data show a positive short time term and, more generally, a constant condition, despite exceptions, in 296 the long term, suggesting that the disease control and surveillance in EU MSs are constant and efficient. 297 Looking into perspective, the steady decline of livestock population in EU over the recent years could 298 help better control zoonotic tuberculosis in the future. 299

The regulatory framework for bovine tuberculosis changed substantially in the EU during 2021. 300 Tuberculosis caused by MTBC infection is currently considered a disease to be controlled in all MSs with 301 the goal of eradicating the disease in bovine animals throughout the EU, while being kept under 302 surveillance in other mammals. All MSs are to have a surveillance, or a control and eradication, 303 programme approved by the European Commission. This should lead, in the coming years, to 304 progressive improvement in the already satisfactory epidemiological situation. In 2023, bovine 305 tuberculosis was reported by 12 MSs and by the United Kingdom (Northern Ireland). Its distribution was 306 highly heterogeneous and spatially clustered in the EU, with a national herd prevalence ranging from 307 0% to 7.2%. 308 In 2023, seventeen MSs had DFS and in addition three UEP MSs had DFS zones. The number of DFS 309 zones increased during 2023. Seven MSs with DFS zones detected bovine tuberculosis, which remained 310 a rare event in these zones, as during the last decade (2014–2023). Seven of the 10 MSs with UEP 311 zones, along with the United Kingdom (Northern Ireland), detected cases of bovine tuberculosis, 312 resulting in an overall herd prevalence of 1.5%, similar to 2022. A 10.7% decrease in MTBC-positive 313 herds was observed compared to 2022, primarily driven by a 42% reduction in MTBC-positive herds 314

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reported by the United Kingdom (Northern Ireland). Over the last decade (2014–2023), the total number 315 of positive cattle herds in UEP zones decreased by 49.4%, whereas the prevalence increased by 3.1%. 316 These varying trends can be attributed for the most part to the decreased number of herds (-51.0%), 317 the gradual progression of DFS in MSs with UEP, and unfavourable environmental conditions hindering 318 the eradication process in several UEP zones. 319 In 2023, M. bovis was reported to be isolated from a wide range of domestic and wild mammal species 320 (other than bovine animals), which is a reflection of the broad host range that this pathogen has. 321 M. caprae, acknowledged to cause bovine tuberculosis, was reported only in cattle and in laboratory 322 macaques. 323 There is a major obstacle to eradication of bovine tuberculosis in areas where infection is endemic in 324 wildlife. Successfully tackling bovine tuberculosis also involves addressing the wildlife reservoir of the 325 disease. In 2018, Ireland introduced a vaccination policy in the Eurasian badger (Meles meles), a species 326 known to be a maintenance host of M. bovis. Among other control measures, Ireland is actively reducing 327 its badger population (Gormley et al., 2017). In contrast, no active badger intervention or vaccination 328 has been carried out in recent years in the United Kingdom (Northern Ireland), which may contribute 329 to the persistently higher prevalence levels there. Stagnating or increasing trends in the prevalence of 330 bovine tuberculosis demonstrate that eradication of this disease is a challenge, owing to the complex 331 interactions between the pathogen, hosts and local environmental factors (EFSA AHAW Panel, 2014). 332 MS-specific evaluations of status, trends and the relevance of bovine tuberculosis as a source of disease 333 for humans can be found in the 2023 Annual National Zoonoses Country Reports available online here. 334

335 Related projects and internet sources 336 337

Subject For more information see

Food/ animals

EURL for Bovine Tuberculosis

https://www.visavet.es/bovinetuberculosis/

Summary presentations on the situation as regards bovine tuberculosis control and eradication programmes in MS

https://food.ec.europa.eu/horizontal-topics/committees/paff- committees/animal-health-and-welfare_en#meetings_2022

Animal Disease Information System (ADIS)

https://food.ec.europa.eu/animals/animal-diseases/animal- disease-information-system-adis_en

Scientific Opinion of the EFSA Panel of Animal Health and Welfare (AHAW): Assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) No 2016/429): bovine tuberculosis

https://www.efsa.europa.eu/en/efsajournal/pub/4959

World Organisation for Animal Health. General Disease Information Sheet on Bovine Tuberculosis

http:/www.oie.int/fileadmin/Home/eng/Media_Center/docs/pdf/ Disease_cards/BOVINE-TB-EN.pdf

SITVITBovis (a WorldWide database of genotyping markers for M. bovis provided by the

http://www.pasteur-guadeloupe.fr:8081/SITVIT_Bovis/

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Institut Pasteur in Guadeloupe) EFSA. Biological hazards report (national zoonosis country reports)

https://www.efsa.europa.eu/en/data-report/biological-hazards- reports

338 Bibliography 339 340 Fujiwara PI, Olea-Popelka F. Why It Is Important to Distinguish Mycobacterium bovis as a Causal Agent 341 of Human Tuberculosis, Clin Infect Dis. 2016;63(5),602–603. https://doi.org/10.1093/cid/ciw374. 342

Devi, K.R., Lee, L.J., Yan, L.T. et al. Occupational exposure and challenges in tackling M. bovis at 343 human–animal interface: a narrative review. Int Arch Occup Environ Health 94, 1147–1171 (2021). 344 https://doi.org/10.1007/s00420-021-01677-zEFSA AHAW Panel (EFSA Panel on Animal Health and 345 Welfare), 2014. Statement on a conceptual framework for bovine tuberculosis. EFSA Journal 346 2014;12(5):3711, 59 pp. doi:10.2903/j.efsa.2014.3711 347 348 Gormley E, Ní Bhuachalla D, O'Keeffe J, Murphy D, Aldwell FE, Fitzsimons T, Stanley P, Tratalos JA, 349 McGrath G, Fogarty N, Kenny K, More SJ, Messam LL, Corner LA. Oral Vaccination of Free-Living Badgers 350 (Meles meles) with Bacille Calmette Guérin (BCG) Vaccine Confers Protection against Tuberculosis. PLoS 351 One. 2017 Jan 25;12(1):e0168851. doi: 10.1371/journal.pone.0168851. 352 353 de la Cruz ML, Pozo P, Grau A, Nacar J, Bezos J, Perez A, Dominguez L, Saez JL, Minguez O, de Juan L, 354 Alvarez J. Assessment of the sensitivity of the bovine tuberculosis eradication program in a high 355 prevalence region of Spain using scenario tree modeling. Prev Vet Med. 2019 Dec 1;173:104800. doi: 356 10.1016/j.prevetmed.2019.104800. 357 358 Byrne AW, Barrett D, Breslin P, Fanning J, Casey M, Madden JM, Lesellier S, Gormley E. Bovine 359 tuberculosis in youngstock cattle: A narrative review. Front Vet Sci. 2022 Sep 23;9:1000124. doi: 360 10.3389/fvets.2022.1000124 361 362 363 Scorpio A, Zhang Y. Mutations in pncA, a gene encoding pyrazinamidase/nicotinamidase, cause 364 resistance to the antituberculous drug pyrazinamide in tubercle bacillus. Nature Medicine. 1996, 2 (6), 365 662-667. https://doi.org/10.1038/nm0696-662 366 367 WHO. Global Tuberculosis Report 2023. 368 369 Acronyms 370 371 ADIS: Animal Disease Information System 372 AHL: Animal Health Law 373 CIR: Commission Implementing Regulation 374 DFS: Disease-free status 375 MS: Member State 376 MTBC: Mycobacterium tuberculosis complex 377 UEP: Under an eradication programme 378 379

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5. Infection with Mycobacterium tuberculosis complex (focusing on 1 Mycobacterium bovis and Mycobacterium caprae) 2

3

The summary data which make up this chapter, as well as additional information on related projects 4 and internet sources, are published for this report on the EFSA Knowledge Junction at Zenodo here. 5 Summary statistics on human surveillance data with downloadable files are retrievable using the ECDC 6 Surveillance Atlas of Infectious Diseases available here. 7

For additional information about zoonotic tuberculosis focusing on Mycobacterium bovis and M. caprae 8 and for the consultation of data collected, the following interactive tools are available: 9

10 11

5.1. Key facts 12

 In 2023, the percentage of zoonotic tuberculosis cases in humans out of total number of 13 tuberculosis cases in humans in the EU/EEA countries was 0.35%. There were 138 confirmed 14 cases of human tuberculosis due to Mycobacterium bovis or Mycobacterium caprae, 15 corresponding to an EU notification rate of 0.04 cases per 100,000 population. This resulted in 16 a notification decrease in the EU of 6.1% compared with 2022. 17

 In 2023 and 2022, the number of cases of human tuberculosis due to M. bovis or M. caprae in 18 the EU remained higher than during the pandemic years 2020 and 2021. In 2023, the number 19 of human cases among the 25 MSs exceeded the number of cases reported in 2019. 20

 In 2023, the M. bovis and M. caprae case notification rate was 0.03 cases per 100,000 among 21 EU MSs with disease-free status and 0.05 cases per 100,000 in EU MSs with non-disease-free 22 status for the bovine population. 23

 The majority of M. bovis and M. caprae cases in humans (48.6%) were of EU origin (native 24 cases and/or cases originating from other MSs). 25

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 In bovine animals, in 2023, the overall prevalence of tuberculosis (0.57%) due to M. bovis or 26 M. caprae decreased slightly compared with the previous year (0.61%), and the number of 27 infected cattle herds in the European Union decreased from 9845 to 8821 herds. 28

 Similar to previous years, the distribution of infected herds was heterogeneous and spatially 29 clustered, with a national herd-level prevalence ranging from <0.01% (Austria, Germany, 30 Poland, Romania) to 7.2% (the United Kingdom (Northern Ireland). 31

 Seventeen Member States had the disease-free status in 2023. Ten Member States, along with 32 the United Kingdom (Northern Ireland), were under an eradication programme, of which three 33 Member States (Italy, Portugal and Spain) had disease-free status zones. 34

 In the disease-free status zones, a total of 162 cattle herds (0.02%) were reported to be 35 infected with the Mycobacterium tuberculosis complex, 13 more compared to 2022, confirming 36 that infection occurs rarely in these areas. 37

 In the zones under an eradication programme 8659 cattle herds (1.5% of the total) tested 38 positive for Mycobacterium tuberculosis complex in 2023, a 10.7% decrease from 9,696 herds 39 in 2022. The United Kingdom (Northern Ireland) (7.2%), Ireland (4.8%) and Spain (3.2%) were 40 the only countries with a prevalence higher than 1%. No positive herds were reported by 41 Bulgaria, Cyprus or Malta. Over the last decade (2014–2023), the total number of positive cattle 42 herds in UEP zones decreased by 49.4%, largely due to the withdrawal of the United Kingdom 43 from the EU in 2020. 44 45

5.2. Surveillance and monitoring of tuberculosis due to Mycobacterium 46 bovis or Mycobacterium caprae in the EU 47

5.2.1. Humans 48

The notification of tuberculosis in humans is mandatory in all MSs and covers the whole population. 49 Countries can update their data retroactively; reported numbers are therefore subject to change in the 50 future or may vary from numbers reported in previous reports. The M. bovis and M. caprae EU 51 notification rate is calculated using the combined population of the EU MSs that reported data in 2023. 52 The proportion of tuberculosis cases caused by M. bovis or M. caprae was calculated using the 53 preliminary estimate of the total number of confirmed tuberculosis cases in 2023 among reporting EU 54 MSs’ species-specific data. In 2023, no human data on M. bovis or M. caprae cases were available for 55 France because this MS did not report species-specific data within the M. tuberculosis complex (MTBC) 56 for human tuberculosis cases. France has not reported species-specific data in any previous years. In 57 addition, Latvia did not report any MTBC data for 2019, 2020, and 2023. 58

Because tuberculosis is a chronic disease with a long incubation period, it is not possible to assess 59 travel-associated cases in the same way as for diseases with acute onset. Instead, a distinction is made 60 between individuals with the disease originating from an EU MS (cases of EU origin) and those 61 originating from outside the EU (case originating outside of the EU). In the analysis, origin is mainly 62 based on the reported birthplace, except for cases from Austria, Belgium, Greece, Hungary and Poland, 63 whose origin is based on reported nationality. 64

5.2.2. Animals 65

Bovine tuberculosis surveillance data 66

Article 2 of Regulation (EU) 2016/429 (the new ‘Animal Health Law’ – AHL) states that its scope 67 applies to transmissible diseases, including zoonoses, without prejudice to the provisions laid down in 68 Directive 2003/99/EC (i.e. the Zoonoses Directive). Therefore, the annual zoonoses data reporting 69 requirements for MSs, as stipulated in Directive 2003/99/EC and implemented by EFSA through specific 70 tools, manuals and guidance, remain unaffected by the entry into force of Commission Implementing 71 Regulation (CIR) (EU) 2020/20021. This latter CIR outlines the compulsory notification and annual 72

1 Commission Implementing Regulation (EU) 2020/2002 of 7 December 2020 laying down rules for the application of Regulation

(EU) 2016/429 of the European Parliament and of the Council with regard to Union notification and Union reporting of listed diseases, to formats and procedures for submission and reporting of Union surveillance programmes and of eradication programmes and for application for recognition of disease-free status, and to the computerised information system, OJ L 412, 8.12.2020, p. 1–28

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reporting obligations that MSs must fulfil with respect to ADIS2: EU MSs need to report to ADIS 73 outbreaks of infection with MTBC in bovine species (cattle, buffalo and bison), even-toed ungulates 74 (Artiodactyla) and other terrestrial mammals. Summaries of these reports are regularly made available 75 online. 76

In accordance with the Zoonoses Directive, MSs must report annual surveillance data for bovine 77 tuberculosis. These data are derived from compulsory national eradication and surveillance programmes 78 implemented in compliance with EU legislation, including the AHL. The reports submitted by MSs are 79 harmonised and enable the assessment of the epidemiological situation and trends analysis across MSs 80 and their zones. 81

Article 36 of Regulation (EU) 2016/429 provides for the European Commission’s approval of the 82 disease-free status (DFS) of MSs or specific zones within them, with respect to MTBC infections. Due to 83 the differing levels of infection risk between DFS zones and zones under an eradication programme 84 (UEP), these zones have been treated separately in this chapter. 85

All cases of bovine tuberculosis caused by the MTBC members (M. bovis, M. caprae or M. 86 tuberculosis) were considered in summarising the EU situation on the disease in cattle. Whenever 87 possible, reporting MSs provided detailed distinctions between these MTBC species. 88

Mycobacterium surveillance data from food and from animals other than bovine animals 89

Mycobacterium spp. monitoring data from food and from animals other than bovine animals are 90 submitted to EFSA in accordance with Directive 2003/99/EC. Data collected allow for descriptive 91 summaries to be compiled at the EU level, but do not allow trend watching or trend analyses (Error! 92 Reference source not found.). 93

In accordance with CIR (EU) 2020/2002, notification to ADIS and surveillance rules apply to other 94 Artiodactyla than bovine animals (such as camelids, cervids, suidae, ovine and caprine animals) and 95 other terrestrial mammals susceptible to infection with MTBC. 96

5.3. Results 97

5.3.1. Overview of key statistics, EU, 2019–2023 98

Error! Reference source not found.summarises the EU-level statistics on human tuberculosis due 99 to M. bovis or M. caprae and on bovine tuberculosis during 2019–2023. More detailed descriptions of 100 these statistics are provided in the subsections below. 101

Table 38: Summary of tuberculosis due to Mycobacterium bovis and 102 Mycobacterium caprae statistics relating to humans and bovine animals 103 (stratified by disease status of MSs/ MS zones), EU, 2019–2023. 104

2023a 2022a 2021a 2020 2019b Data

source

Humans

Number of confirmed M. bovis cases 129 140 108 95 141 ECDC

Number of confirmed M. caprae cases 9 7 10 4 11 ECDC

Total number of confirmed cases 138 147 118 99 152 ECDC

Total number of confirmed cases/100,000 population (notification rates) 0.04 0.04 0.03 0.03 0.03 ECDC

Number of EU MSs that reported data on M. bovis or M. caprae cases

25 26 26 25 26 ECDC

M. bovis or M. caprae cases in individuals of EU origin

67 93 63 60 107 ECDC

M. bovis or M. caprae cases in individuals originating from outside EU 62 47 49 35 40 ECDC

M. bovis or M. caprae cases in individuals of unknown origin

9 7 6 4 5 ECDC

2 EU Animal Diseases Information System (ADIS). More information is available at: https://food.ec.europa.eu/animals/animal-

diseases/animal-disease-information-system-adis_en

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Total number of foodborne outbreaksc 1 0 0 0 0 EFSA

Number of outbreak-related cases 3 0 0 0 0 EFSA

Bovine animals

Number of infected herds in disease-free status zonesd

162 149 139 139 143 EFSA

Number of reporting disease-free status MSsd 17 17 17 17 17 EFSA

Number of infected herds in zones under an eradication programmee

8,659 9,696 9,255 7,233 16,277 EFSA

Number of reporting MSs with zones under an eradication programmee

11 11 11 9f 11 EFSA

Abbreviations: ECDC, European Centre for Disease Prevention and Control; EFSA, European Food Safety Authority; MSs, Member 105 States. 106

aData from the United Kingdom (Northern Ireland) were taken into account for 2021–2023. In accordance with the Agreement 107 on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European 108 Atomic Energy Community, and in particular Article 5(4) of the Windsor Framework (see Joint Declaration No 1/2023 of the 109 Union and the United Kingdom in the Joint Committee established by the Agreement on the withdrawal of the United Kingdom 110 of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community of 24 March 2023, 111 OJ L 102, 17.4.2023, p.87) in conjunction with section 24 of Annex 2 to that Framework, for the purposes of this Regulation, 112 references to Member States include the United Kingdom in respect of Northern Ireland. 113

bData from the United Kingdom were taken into account for the 2018–2019 period, since the United Kingdom was still an EU MS 114 at that time. However, on 1 February 2020 it became a third country. 115

cNo information on the species was available for the Mycobacterium outbreak reported in 2023 116 dMember States, or zones thereof, with disease-free status regarding infection with the Mycobacterium tuberculosis complex (M. 117

bovis, M. caprae, M. tuberculosis (MTBC) in their bovine animal population. 118 eThe Member States or zones thereof with an approved eradication programme (UEP) for infection with MTBC. In addition, the 119

United Kingdom (Northern Ireland) has an approved eradication programme for infection with MTBC. 120 fNo data reported from Bulgaria. 121

5.3.2. Tuberculosis due to Mycobacterium bovis or Mycobacterium caprae in 122 humans 123

In 2023, 138 confirmed human cases of tuberculosis due to M. bovis or M. caprae were reported from 124 13 MSs (Austria, Belgium, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Netherlands, 125 Romania, Spain and Sweden) (Table 39: ). Tuberculosis cases due to M. bovis (129 cases) were reported 126 from all the above mentioned MSs except Hungary, which only reported cases caused by M. caprae. 127 Austria, Germany and Spain also reported cases due to M. caprae, which accounted altogether for 9 128 cases in the EU. 129

In 2023, tuberculosis cases due to M. bovis or M. caprae accounted for a small proportion (0.35%) of 130 total tuberculosis cases reported in the EU, Iceland, Norway, Liechtenstein and Switzerland. Overall, 25 131 MSs reported species-specific data on MTBC while twelve MSs did not report any cases. Reported cases 132 of human tuberculosis due to M. bovis or M. caprae in the EU slightly decreased in 2023 compared to 133 2022 but remained high when compared to the 2020-2021 COVID-19 pandemic years. 134

The EU notification rate in 2023 was 0.036 cases per 100,000 population, which was a decrease of 6.1% 135 compared with 2022, when the notification rate was 0.039 per 100,000 population. In 2023, the highest 136 notification rate was reported by Ireland (0.15 per 100,000), followed by Spain (0.11 per 100,000). 137

Among the 17 MSs with disease-free status (DFS) in 2023, 15 MSs reported on MTBC species. M. bovis 138 and M. caprae human cases were reported in eight MSs. The notification rate in these MSs reporting on 139 MTBC species was 0.03 cases per 100,000 population. The notification rate for M. bovis and M. caprae 140 human cases reported in the 10 non-DFS MSs in 2023 was 0.05 cases per 100,000 population. 141

The majority of the M. bovis and M. caprae human cases reported in 2023 (67/138; 48.6%) were of EU 142 origin (native cases and/or cases originating from other MSs). The other cases originated from outside 143 the EU (N = 62; 44.9%) or had unknown origin (N = 9; 6.5%) (Table 38: ). Notification rates of M. bovis 144 and M. caprae human cases of EU origin were lower in disease-free MSs (N = 26; 38.8%) than in non-145 disease-free MSs (N = 41; 61.2%). 146

Table 39: Reported confirmed human cases of tuberculosis due to Mycobacterium bovis or 147 Mycobacterium caprae and notification rates per 100,000 population in EU MS and non-MS countries, 148 by country and year, 2019–2023. 149

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Country

2023 2022 2021 2020 2019

Status National

coveragea Data

formata

Confirmed cases and

rates

Confirmed cases and

rates

Confirmed cases and

rates

Confirmed cases and

rates

Confirmed cases and

rates Cases Rate Cases Rate Cases Rate Cases Rate Cases Rate

Austria DFS Y C 3 0.03 5 0.06 4 0.04 0 0 3 0.03 Belgium DFS Y C 3 0.03 9 0.08 10 0.09 6 0.05 0 0 Bulgaria Y C 0 0 0 0 0 0 0 0 0 0 Croatia Y C 0 0 0 0 0 0 0 0 0 0 Cyprus Y C 0 0 0 0 0 0 0 0 0 0 Czechia DFS Y C 0 0 0 0 0 0 0 0 0 0 Denmark DFS Y C 1 0.02 0 0 0 0 0 0 0 0 Estonia DFS Y C 0 0 0 0 0 0 0 0 0 0 Finland DFS Y C 1 0.02 0 0 0 0 1 0.02 0 0 Franceb DFS – – – – – – – – – – – – Germany DFS Y C 48 0.06 38 0.05 44 0.05 37 0.04 51 0.06 Greece Y C 1 0.01 1 0.01 0 0 2 0.02 1 0.01 Hungary DFS Y C 1 0.01 0 0 0 0 0 0 0 0 Ireland Y C 8 0.15 7 0.14 2 0.04 4 0.08 7 0.14 Italy Y C 8 0.01 15 0.03 12 0.02 6 0.01 11 0.02 Latviac DFS Y C – – 0 0 0 0 – – – – Lithuania DFS Y C 0 0 0 0 0 0 0 0 0 0 Luxembourg DFS Y C 0 0 0 0 0 0 0 0 0 0 Malta Y C 0 0 0 0 0 0 0 0 0 0 Netherlands DFS Y C 6 0.03 5 0.03 5 0.03 6 0.03 5 0.03

Poland DFS Y C 0 0 1 < 0.01 0 0 0 0 0 0

Portugal Y C 0 0 0 0 0 0 0 0 0 0 Romania Y C 3 0.02 1 0.01 0 0 1 0.01 1 0.01 Slovakia DFS Y C 0 0 0 0 0 0 0 0 0 0 Slovenia DFS Y C 0 0 0 0 0 0 0 0 0 0 Spain Y C 54 0.11 59 0.12 37 0.08 30 0.06 35 0.07 Sweden DFS Y C 1 0.01 6 0.06 4 0.04 6 0.06 3 0.03

EU Total 27 138 0.04 147 0.04 118 0.03 99 0.03 117 0.03 United Kingdom

– – – – – – – – – – 35 0.05

EU Total 138 0.04 147 0.04 118 0.03 99 0.03 152 0.03

Icelandd Y C 0 0 0 0 0 0 0 0 0 0 Norway DFS Y C 1 0.02 0 0 0 0 0 0 1 0.02 Liechtenstein DFS Y C 0 0 0 0 0 0

3 0.03 4 0.05 Switzerlande DFS Y C 10 0.11 1 0.01 4 0.05

Abbreviations: –, Data not reported; DFS, Disease-free status, i.e. free of infection with M. bovis, M. caprae or M. tuberculosis in 150 the bovine animal population. 151 aY: yes; N: no; A: aggregated data; C: case-based data. 152 bNo surveillance system. 153 cLatvia did not report any MTBC data during 2019–2020 and 2023 154 dIn Iceland, which has no special agreement concerning animal health (status) with the EU, the last outbreak of bovine tuberculosis 155 was in 1959. 156 eSwitzerland provided data directly to EFSA. The human data for Switzerland include data from Liechtenstein for the years 2019–157 2020. 158

159

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Figure 10 shows, for year 2023, the number of confirmed tuberculosis cases due to M. bovis or M. 160 caprae in individuals of EU origin overlaid with the national aggregated herd prevalence of bovine 161 tuberculosis. 162

163 Member States that reported data at the national level without specifying the specific zones or overseas territories where the 164 bovine tuberculosis-positive cattle herds were detected, were assigned the same color for all their zones, including overseas 165 territories. For Albania, Kosovo and Serbia, prevalence data refer to animal tested. 166

Map of the number of confirmed tuberculosis cases due to Mycobacterium bovis or 167 Mycobacterium caprae in individuals of EU origin, and national herd prevalence of tuberculosis in the 168 bovine animal population in EU MS and non-MS countries, 2023 169

5.3.3. Mycobacterium in food 170

No Mycobacterium species monitoring data from food were submitted for the year 2023. 171

5.3.4. Tuberculosis in bovine animals 172

Bovine tuberculosis surveillance data 173

Seventeen MSs had DFS regarding MTBC during 2023 (Error! Reference source not found.). Of the 174 remaining 10 MSs and the United Kingdom (Northern Ireland), three MSs had DFS zones or provinces: 175

- Italy: 12 regions and 23 provinces; 176 - Portugal: two regions (Algarve and Azores, except the island of São Miguel); 177 - Spain: seven autonomous communities and three provinces. 178

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Seven MSs had no zones with DFS regarding MTBC. The United Kingdom (Northern Ireland) had no DFS 179 zones either. 180 Norway, Switzerland and Liechtenstein had DFS, in accordance with the EU legislation. In Iceland, which 181 has no special agreement with the EU on animal health status, the last outbreak of bovine tuberculosis 182 was reported in 1959. A map of EU MSs’ disease status is available at link here. 183 In 2023, the overall proportion of cattle herds in the EU infected with MTBC was very low, 0.57%, a 184 slight decrease from 0.61% in 2022. The total number of infected bovine herds in the EU also decreased, 185 from 9845 in 2022 to 8821 in 2023. 186 Fifteen MSs (12 DFS and three UEP countries) reported no cases of bovine tuberculosis. The remaining 187 12 MSs and the United Kingdom (Northern Ireland) reported cases of bovine tuberculosis, with 188 prevalence varying widely at the national level. MTBC infections were primarily concentrated in UEP 189 zones, where the overall prevalence of infected herds (1.5%) was 85 times higher than in DFS zones 190 (0.02%). 191 Five MSs reported MTBC infections in cattle without specifying the Mycobacterium species. M. bovis was 192 specifically detected in France, Germany, Ireland, Italy, Poland, Romania and the United Kingdom 193 (Northern Ireland), while M. caprae was specifically reported in Austria, Germany and Romania. No 194 cases of M. tuberculosis infection in cattle herds were reported. 195

MSs and MSs’ zones with disease-free status regarding Mycobacterium tuberculosis 196 complex infection 197

The majority of the EU’s cattle herd population (61.4%) is located in the DFS zones across 20 MSs. 198 However, the number of cattle herds in these zones has steadily declined, with a 27.6% decrease over 199 the last decade (2014–2023). Over this 10-year period there was a slight increase in both the number 200 of infected herds and the prevalence of MTBC-infected herds (Figure 11: ). 201

Seven MSs with DFS zones reported a total of 162 MTBC-infected bovine herds, confirming that the 202 detection of bovine tuberculosis in DFS zones is rare. When comparing 2023 to 2022, the number of 203 infected cattle herds increased by 13, while the prevalence remained unchanged at 0.02%. The total 204 number of cattle herds decreased by 2.9%. 205

206

207 (*): In contrast to years 2014–2019, the year 2020 does not include the United Kingdom (Scotland) data. Since 1 February 2020, 208

the United Kingdom has withdrawn from the EU and has become a third country. 209

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Prevalence of cattle herds infected with the Mycobacterium tuberculosis complex in 210 disease-free status (DFS) zones, EU, 2014–2023 211

MSs and MSs’ zones with an approved eradication programme for infection with 212 Mycobacterium tuberculosis complex 213

In 2023, cattle herds from UEP zones across 10 MSs and the United Kingdom (Northern Ireland) 214 represented 38.6% of the total EU cattle herd population. This population has been steadily declining, 215 with a 51.0% decrease compared to 2014 (Figure 12: ). Over the last decade (2014–2023), the 216 prevalence of bovine tuberculosis in UEP zones has shown varying trends. From 2014 to 2019, data 217 included the EU-28 MSs. However, the sharp decrease in 2020 can be attributed to the withdrawal of 218 the United Kingdom from the EU and to the absence of data from Bulgaria in that year. Starting from 219 2021, the increase in the number of reported cattle herds can be mainly explained by the resumption 220 of data from Bulgaria after its 2020 hiatus and by the inclusion of data from the United Kingdom 221 (Northern Ireland)3. Over the last decade (2014–2023), the total number of positive cattle herds in UEP 222 zones decreased by 49.4%, whereas the prevalence increased by 3.1%. 223 Seven Member States and the United Kingdom (Northern Ireland) reported a total of 8659 herds positive 224 for bovine tuberculosis in 2023, a 10.7% decrease from 9,696 herds in 2022. This reduction was 225 primarily driven by the United Kingdom (Northern Ireland), which had reported 2,785 (12.2%) MTBC-226 positive herds in 2022. The United Kingdom (Northern Ireland) (7.2%), Ireland (4.8%) and Spain 227 (3.2%) were the only countries with a prevalence higher than 1%. No positive herds were reported by 228 Bulgaria, Cyprus or Malta. Compared with 2022, the overall prevalence in UEP zones remained stable 229 at around 1.5%. 230 231 232

3 Data from the United Kingdom (Northern Ireland) were taken into account for 2021–2023. In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Windsor Framework (see Joint Declaration No 1/2023 of the Union and the United Kingdom in the Joint Committee established by 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 of 24 March 2023, OJ L 102, 17.4.2023, p.87) in conjunction with section 24 of Annex 2 to that Framework, for the purposes of this Regulation, references to Member States include the United Kingdom in respect of Northern Ireland

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233 * In contrast to years 2014–2019, year 2020 does not include the United Kingdom data. Since 1 February 2020, the United 234 Kingdom has withdrawn from the EU and has become a third country. No 2020 data were reported from Bulgaria. 235 ** Data from the United Kingdom (Northern Ireland) were taken into account for 2021–2023. In accordance with the Agreement 236

on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European 237 Atomic Energy Community, and in particular Article 5(4) of the Windsor Framework (see Joint Declaration No 1/2023 of the 238 Union and the United Kingdom in the Joint Committee established by the Agreement on the withdrawal of the United Kingdom 239 of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community of 24 March 2023, 240 OJ L 102, 17.4.2023, p.87) in conjunction with Section 24 of Annex 2 to that Framework, for the purposes of this Regulation, 241 references to MSs include the United Kingdom in respect of Northern Ireland. 242

Prevalence of cattle herds positive for bovine tuberculosis in zones under an eradication 243 programme (UEP), EU, 2014–2023 244

Non-Member States and pre-accession countries 245

Bovine tuberculosis was not detected in 2023 in Iceland, Liechtenstein or Switzerland, whereas Norway 246 reported one infected cattle herd and a herd prevalence of 0.01%. Among the pre-accession countries, 247 Montenegro, as in the previous 3 years, reported no infected herds; the Republic of North Macedonia 248 reported a herd prevalence of 0.08% (10/12,621), whereas Albania reported a prevalence of 0.01% 249 (7/94,252). Kosovo4 reported a prevalence of 0.07% intradermal tuberculin skin test-positive bovines 250 (17/25,000)5. 251

5.3.5. Mycobacterium tuberculosis complex surveillance data from animals other 252 than bovine animals 253

In 2023, two MSs (Finland, Sweden), the United Kingdom (Northern Ireland) and one non-MS (Norway) 254 reported surveillance data on infection in farmed deer. In particular, Sweden reported data from a 255 control programme in farmed deer. One case of MTBC infection in farmed deer was reported by the 256 United Kingdom (Northern Ireland). 257

MSs also reported cases of MTBC infection in other mammal species. In particular, M. bovis was detected 258 in farmed alpacas (Ireland), goats (France, Ireland), pigs (France, Ireland, Italy, the United Kingdom 259

4 This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence. 5 The prevalence reported by Kosovo in 2022 was 3.1% (78/2,500).

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(Northern Ireland)), cats (France, Switzerland, the United Kingdom (Northern Ireland)), wild deer (Italy, 260 Ireland), wild boar (Spain, France, Italy) and badgers (France, Ireland, the United Kingdom (Northern 261 Ireland)). M. caprae was detected in laboratory monkeys (France). Finally, M. tuberculosis was detected 262 in an African elephant (zoo animal) in Switzerland. 263 264 Refer to the dashboard mentioned at the beginning of the chapter for detailed insights. 265

5.4. Discussion 266

In 2023, the reporting of human tuberculosis due to M. bovis and M. caprae resulted in a total of 267 138 cases, a decrease compared with year 2022. This corresponded in a relative notification decrease 268 of 6.1% in 2023 (0.036 cases per 100,000) compared with 2022 (0.039 per 100,000 population). In 269 particular, the decrease was due to M. bovis cases, by far the most frequent infection compared to M. 270 caprae cases. Total cases of M. caprae appear to be relatively constant over the years. It is important 271 to highlight that analysing the last 5 years trend, notification cases are still higher in 2022-2023 than in 272 the previous 3 years, but this fact is mainly due to the increased number of cases in Spain. Taken all 273 together, in the other countries a relatively stable epidemiological situation was observed during the 274 long period, suggesting the normalization of the effect of the COVID-19 pandemic on human cases. 275

The specific analysis by countries showed that 12 MSs reported no cases. In addition, notification of 276 total cases noticeably decreased in Austria, Belgium, Italy, Spain and Sweden. In contrast, some 277 countries showed an increase of total cases, particularly Germany. As expected, the total number of 278 cases were highest in Germany and Spain but when the data were referred to the human population, 279 the highest notification rates were observed for Ireland and Spain, i.e. both countries with no disease 280 free status for tuberculosis in bovine population demonstrating the importance of reaching a full disease-281 free status. The number of notifications clearly depends on efficient surveillance standards and rapid 282 diagnostic intervention. Finally, France and Latvia did not report any MTBC data in 2023. When checking 283 the native versus foreigner's ratio, for the first year the number approaches to 1, with native total 284 notification numbers being constant over the recent years, whereas foreigner cases tend to increase, 285 likely because of the resumption of the population movement after the COVID-19 pandemic restrictions. 286

Tuberculosis cases of zoonotic origin (due to M. bovis or M. caprae) and notification rates are highly 287 likely to have been underestimated. Bias is introduced by those EU MSs that do not regularly perform 288 routine tests to distinguish M. bovis and M. caprae from M. tuberculosis, resulting in under-notification 289 at the EU level, because all cases in those MSs are reported as M. tuberculosis, and undermining the 290 possibility of tracing the origin of infections (Fujiwara and Olea-Popelka, 2016). Furthermore, a lower 291 notification rate was observed in EU MSs with DFS compared with non-DFS MSs, supporting the 292 effectiveness of the surveillance programmes. 293

In conclusion, despite a general alarm that occupational exposure to zoonotic tuberculosis is an 294 underestimated threat, in particular in developing countries (Devi, Lee, et al, 2021), EU 2023 human 295 data show a positive short time term and, more generally, a constant condition, despite exceptions, in 296 the long term, suggesting that the disease control and surveillance in EU MSs are constant and efficient. 297 Looking into perspective, the steady decline of livestock population in EU over the recent years could 298 help better control zoonotic tuberculosis in the future. 299

The regulatory framework for bovine tuberculosis changed substantially in the EU during 2021. 300 Tuberculosis caused by MTBC infection is currently considered a disease to be controlled in all MSs with 301 the goal of eradicating the disease in bovine animals throughout the EU, while being kept under 302 surveillance in other mammals. All MSs are to have a surveillance, or a control and eradication, 303 programme approved by the European Commission. This should lead, in the coming years, to 304 progressive improvement in the already satisfactory epidemiological situation. In 2023, bovine 305 tuberculosis was reported by 12 MSs and by the United Kingdom (Northern Ireland). Its distribution was 306 highly heterogeneous and spatially clustered in the EU, with a national herd prevalence ranging from 307 0% to 7.2%. 308 In 2023, seventeen MSs had DFS and in addition three UEP MSs had DFS zones. The number of DFS 309 zones increased during 2023. Seven MSs with DFS zones detected bovine tuberculosis, which remained 310 a rare event in these zones, as during the last decade (2014–2023). Seven of the 10 MSs with UEP 311 zones, along with the United Kingdom (Northern Ireland), detected cases of bovine tuberculosis, 312 resulting in an overall herd prevalence of 1.5%, similar to 2022. A 10.7% decrease in MTBC-positive 313 herds was observed compared to 2022, primarily driven by a 42% reduction in MTBC-positive herds 314

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reported by the United Kingdom (Northern Ireland). Over the last decade (2014–2023), the total number 315 of positive cattle herds in UEP zones decreased by 49.4%, whereas the prevalence increased by 3.1%. 316 These varying trends can be attributed for the most part to the decreased number of herds (-51.0%), 317 the gradual progression of DFS in MSs with UEP, and unfavourable environmental conditions hindering 318 the eradication process in several UEP zones. 319 In 2023, M. bovis was reported to be isolated from a wide range of domestic and wild mammal species 320 (other than bovine animals), which is a reflection of the broad host range that this pathogen has. 321 M. caprae, acknowledged to cause bovine tuberculosis, was reported only in cattle and in laboratory 322 macaques. 323 There is a major obstacle to eradication of bovine tuberculosis in areas where infection is endemic in 324 wildlife. Successfully tackling bovine tuberculosis also involves addressing the wildlife reservoir of the 325 disease. In 2018, Ireland introduced a vaccination policy in the Eurasian badger (Meles meles), a species 326 known to be a maintenance host of M. bovis. Among other control measures, Ireland is actively reducing 327 its badger population (Gormley et al., 2017). In contrast, no active badger intervention or vaccination 328 has been carried out in recent years in the United Kingdom (Northern Ireland), which may contribute 329 to the persistently higher prevalence levels there. Stagnating or increasing trends in the prevalence of 330 bovine tuberculosis demonstrate that eradication of this disease is a challenge, owing to the complex 331 interactions between the pathogen, hosts and local environmental factors (EFSA AHAW Panel, 2014). 332 MS-specific evaluations of status, trends and the relevance of bovine tuberculosis as a source of disease 333 for humans can be found in the 2023 Annual National Zoonoses Country Reports available online here. 334

335 Related projects and internet sources 336 337

Subject For more information see

Food/ animals

EURL for Bovine Tuberculosis

https://www.visavet.es/bovinetuberculosis/

Summary presentations on the situation as regards bovine tuberculosis control and eradication programmes in MS

https://food.ec.europa.eu/horizontal-topics/committees/paff- committees/animal-health-and-welfare_en#meetings_2022

Animal Disease Information System (ADIS)

https://food.ec.europa.eu/animals/animal-diseases/animal- disease-information-system-adis_en

Scientific Opinion of the EFSA Panel of Animal Health and Welfare (AHAW): Assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) No 2016/429): bovine tuberculosis

https://www.efsa.europa.eu/en/efsajournal/pub/4959

World Organisation for Animal Health. General Disease Information Sheet on Bovine Tuberculosis

http:/www.oie.int/fileadmin/Home/eng/Media_Center/docs/pdf/ Disease_cards/BOVINE-TB-EN.pdf

SITVITBovis (a WorldWide database of genotyping markers for M. bovis provided by the

http://www.pasteur-guadeloupe.fr:8081/SITVIT_Bovis/

EU One Health Zoonoses Report 2023

www.efsa.europa.eu/efsajournal EFSA Journal 20YY:XX(X):NNNN 12

Institut Pasteur in Guadeloupe) EFSA. Biological hazards report (national zoonosis country reports)

https://www.efsa.europa.eu/en/data-report/biological-hazards- reports

338 Bibliography 339 340 Fujiwara PI, Olea-Popelka F. Why It Is Important to Distinguish Mycobacterium bovis as a Causal Agent 341 of Human Tuberculosis, Clin Infect Dis. 2016;63(5),602–603. https://doi.org/10.1093/cid/ciw374. 342

Devi, K.R., Lee, L.J., Yan, L.T. et al. Occupational exposure and challenges in tackling M. bovis at 343 human–animal interface: a narrative review. Int Arch Occup Environ Health 94, 1147–1171 (2021). 344 https://doi.org/10.1007/s00420-021-01677-zEFSA AHAW Panel (EFSA Panel on Animal Health and 345 Welfare), 2014. Statement on a conceptual framework for bovine tuberculosis. EFSA Journal 346 2014;12(5):3711, 59 pp. doi:10.2903/j.efsa.2014.3711 347 348 Gormley E, Ní Bhuachalla D, O'Keeffe J, Murphy D, Aldwell FE, Fitzsimons T, Stanley P, Tratalos JA, 349 McGrath G, Fogarty N, Kenny K, More SJ, Messam LL, Corner LA. Oral Vaccination of Free-Living Badgers 350 (Meles meles) with Bacille Calmette Guérin (BCG) Vaccine Confers Protection against Tuberculosis. PLoS 351 One. 2017 Jan 25;12(1):e0168851. doi: 10.1371/journal.pone.0168851. 352 353 de la Cruz ML, Pozo P, Grau A, Nacar J, Bezos J, Perez A, Dominguez L, Saez JL, Minguez O, de Juan L, 354 Alvarez J. Assessment of the sensitivity of the bovine tuberculosis eradication program in a high 355 prevalence region of Spain using scenario tree modeling. Prev Vet Med. 2019 Dec 1;173:104800. doi: 356 10.1016/j.prevetmed.2019.104800. 357 358 Byrne AW, Barrett D, Breslin P, Fanning J, Casey M, Madden JM, Lesellier S, Gormley E. Bovine 359 tuberculosis in youngstock cattle: A narrative review. Front Vet Sci. 2022 Sep 23;9:1000124. doi: 360 10.3389/fvets.2022.1000124 361 362 363 Scorpio A, Zhang Y. Mutations in pncA, a gene encoding pyrazinamidase/nicotinamidase, cause 364 resistance to the antituberculous drug pyrazinamide in tubercle bacillus. Nature Medicine. 1996, 2 (6), 365 662-667. https://doi.org/10.1038/nm0696-662 366 367 WHO. Global Tuberculosis Report 2023. 368 369 Acronyms 370 371 ADIS: Animal Disease Information System 372 AHL: Animal Health Law 373 CIR: Commission Implementing Regulation 374 DFS: Disease-free status 375 MS: Member State 376 MTBC: Mycobacterium tuberculosis complex 377 UEP: Under an eradication programme 378 379