natgillin/translations-raw huggingface dataset:
HAS ADOPTED THIS REGULATION:
Odločba 2007/182/ES se razveljavi.
Annexes I and III of Regulation (EC) No 999/2001 are amended in accordance with the Annex to this Regulation.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
Decision 2007/182/EC is repealed.
V Bruslju, 30. oktobra 2017
Done at Brussels, 30 October 2017.
Znanstveno mnenje o bolezni kroničnega hiranja pri jelenih (Scientific Opinion on Chronic wasting disease (CWD) in cervids), The EFSA Journal (2017);15(1):46.
For the Commission
Odločba Komisije 2007/182/ES z dne 19. marca 2007 o raziskavi v zvezi z boleznijo kroničnega hiranja pri jelenih (UL L 84, 24.3.2007, str. 37).
OJ L 147, 31.5.2001, p. 1.
Prilogi I in III k Uredbi (ES) št. 999/2001 se spremenita:
Scientific Opinion on Chronic wasting disease (CWD) in cervids, The EFSA Journal (2017);15(1):46.
V točki 2 Priloge I se doda naslednje:
Commission Decision 2007/182/EC of 19 March 2007 on a survey for chronic wasting disease in cervids (OJ L 84, 24.3.2007, p. 37).
„gojeni jeleni in jeleni v ujetništvu“ so živali iz družine Cervidae, ki jih ljudje gojijo na zaprtem območju;
ANNEX
„divji jeleni“ so živali iz družine Cervidae, ki jih ne gojijo ljudje;
Annexes I and III to Regulation (EC) No 999/2001 are amended as follows:
„delno udomačeni jeleni“ so živali iz družine Cervidae, ki jih ljudje sicer gojijo, vendar ne na zaprtem območju.“
In Annex I the following items are added to point 2:
Priloga III se spremeni:
‘farmed and captive cervids’ means animals of the family Cervidae which are kept by humans in an enclosed territory.
v poglavju A se del III nadomesti z naslednjim:
‘wild cervids’ means animals of the family Cervidae which are not kept by humans.
SPREMLJANJE PRI JELENIH
‘semi-domesticated cervids’ means animals of the family Cervidae which are kept by humans although not in an enclosed territory.’
A. Triletni program spremljanja bolezni kroničnega hiranja
Annex III is amended as follows:
Splošno
In Chapter A, Part III is replaced by the following:
Države članice s populacijo divjih in/ali gojenih in/ali delno udomačenih losov in/ali severnih jelenov (Estonija, Finska, Latvija, Litva, Poljska in Švedska) izvajajo triletni program spremljanja bolezni kroničnega hiranja pri jelenih, in sicer od 1. januarja 2018 do 31. decembra 2020.
MONITORING IN CERVIDS
Testi na TSE v okviru tega programa spremljanja se izvedejo med 1. januarjem 2018 in 31. decembrom 2020, medtem ko se odvzem vzorcev v okviru programa spremljanja lahko začne že leta 2017.
A. Three-year monitoring programme for chronic wasting disease (CWD)
Triletni program spremljanja bolezni kroničnega hiranja zajema naslednje vrste jelenov:
General
Evrazijski tundrski severni jelen (Rangifer tarandus tarandus);
The Member States which have a wild and/or farmed and/or semi-domesticated population of moose and/or reindeer (Estonia, Finland, Latvia, Lithuania, Poland and Sweden) shall carry out a three-year monitoring programme for CWD in cervids, from 1 January 2018 to 31 December 2020.
finski gozdni severni jelen (Rangifer tarandus fennicus);
The TSE tests performed for the purpose of this monitoring programme shall take place between 1 January 2018 and 31 December 2020, however, the collection of samples for the purpose of the monitoring programme may, however, start in 2017.
los (Alces alces);
The three-year CWD monitoring programme shall cover the following cervid species:
srna (Capreolus capreolus);
Eurasian tundra reindeer (Rangifer tarandus tarandus);
virginijski jelen (Odocoileus virginianus);
Finnish forest reindeer (Rangifer tarandus fennicus);
navadni jelen (Cervus elaphus).
Moose (Alces alces);
Z odstopanjem od točke 1.2 lahko država članica na podlagi dokumentirane ocene tveganja, predložene Evropski komisiji, za triletni program spremljanja bolezni kroničnega hiranja izbere podskupino vrst iz navedene točke.
Roe deer (Capreolus capreolus);
Načrt vzorčenja
White-tailed deer (Odocoileus virginianus);
Države članice iz točke 1.1 opredelijo primarne enote vzorčenja, ki zajemajo celotna območja, na katerih so prisotne populacije jelenov, z uporabo vsaj naslednjih elementov:
Red deer (Cervus elaphus).
za gojene jelene in jelene v ujetništvu se vsaka kmetija in vsak obrat, na katerih se jeleni gojijo na zaprtem območju, šteje za primarno enoto vzorčenja;
By way of derogation from point 1.2, a Member State may, based on a documented risk assessment submitted to the European Commission, select for the three-year CWD monitoring programme a subset of the species listed in that point.
za divje in delno udomačene jelene se primarna enota vzorčenja opredeli geografsko na podlagi naslednjih meril:
Sampling design
območja, kjer se divje in delno udomačene živali vrst iz programa spremljanja zbirajo vsaj v določenem obdobju leta;
The Member States referred to in point 1.1 shall identify Primary Sampling Units (PSU), which shall cover all territories in which cervid populations are present, using at least the following elements:
če se živali vrst ne zbirajo, območja, naravno ali umetno ograjena, kjer so prisotne živali vrst iz programa spremljanja;
for farmed and captive cervids, each farm and each facility in which cervids are kept in an enclosed territory shall be considered as a PSU.
območja, kjer se lovijo živali vrst iz programa spremljanja, in območja, povezana z drugimi relevantnimi dejavnostmi v zvezi z vrstami iz programa spremljanja.
for wild and semi-domesticated cervids, PSU shall be defined geographically based on the following criteria:
za gojene jelene in jelene v ujetništvu:
the areas in which wild and semi-domesticated animals of a species covered by the monitoring programme gather in at least a certain period of the year;
med triletnim obdobjem programa spremljanja naključno izberejo 100 primarnih enot vzorčenja, s čimer se zagotovi geografska reprezentativnost in po potrebi upoštevajo relevantni dejavniki tveganja iz dokumentirane ocene tveganja, ki jo opravi država članica; ali
the areas in which animals of the species covered by the monitoring programme are hunted and areas connected to other relevant activities related to the species covered by the monitoring programme.
za divje jelene in delno udomačene jelene:
The Member States referred to in point 1.1 shall select farmed, captive, wild and semi-domesticated cervids for TSE testing using the following two-stage sampling approach: (a) in the first stage, those Member States shall:
če država članica ni uspela opredeliti 100 primarnih enot vzorčenja za divje jelene in delno udomačene jelene, se izberejo vse opredeljene primarne enote vzorčenja;
for farmed and captive cervids:
na drugi stopnji:
select, on a random basis ensuring geographical representativeness, and if relevant taking into account relevant risk factors identified in a documented risk assessment carried out by the Member State, 100 PSU to be covered over the three-year period of the monitoring programme, or
država članica, ki je izbrala 100 primarnih enot vzorčenja, znotraj vsake izbrane primarne enote vzorčenja odvzame vzorce vsem živalim iz ciljnih skupin iz točke 2.4.(a) med triletnim obdobjem, dokler ne doseže cilja 30 testiranih živali na primarno enoto vzorčenja.
if the Member State was unable to identify 100 PSU for farmed and captive cervids, select all PSU identified.
Če pa v nekaterih primarnih enotah vzorčenja ni mogoče doseči cilja 30 testiranih živali med triletnim obdobjem zaradi omejene velikosti populacije jelenov, se vzorčenje živali iz ciljnih skupin iz točke 2.4.(a) lahko nadaljuje v večjih primarnih enotah vzorčenja, tudi ko se doseže cilj 30 testiranih živali, da se doseže skupno število do 3000 gojenih jelenov in jelenov v ujetništvu, kadar je to mogoče, testiranih na nacionalni ravni med triletnim obdobjem programa spremljanja;
For wild and semi-domesticated cervids:
država članica, ki je opredelila manj kot 100 primarnih enot vzorčenja, znotraj vsake primarne enote vzorčenja odvzame vzorce vsem živalim iz ciljnih skupin iz točke 2.4.(a) med triletnim obdobjem, da se približa skupnemu številu do 3000 gojenih jelenov in jelenov v ujetništvu, kadar je to mogoče, testiranih na nacionalni ravni med triletnim obdobjem programa spremljanja;
if the Member State was unable to identify 100 PSU for wild and semi-domesticated cervids, select all PSU identified.
za divje jelene in delno udomačene jelene:
in the second stage:
država članica, ki je izbrala 100 primarnih enot vzorčenja, znotraj vsake izbrane primarne enote vzorčenja odvzame vzorce vsem živalim iz ciljnih skupin iz točke 2.4.(b) med triletnim obdobjem, dokler ne doseže cilja 30 testiranih živali na primarno enoto vzorčenja, da doseže skupno število do 3000 divjih jelenov in delno udomačenih jelenov, testiranih na nacionalni ravni med triletnim obdobjem;
a Member State having selected 100 PSU shall, within every selected PSU, sample all animals belonging to the target groups listed under point 2.4.(a) over the three-year period until a target of 30 animals tested per PSU is reached.
država članica, ki je opredelila manj kot 100 primarnih enot vzorčenja, znotraj vsake primarne enote vzorčenja odvzame vzorce vsem živalim iz ciljnih skupin iz točke 2.4.(b) med triletnim obdobjem, da se približa skupnemu številu 3000 divjih jelenov in delno udomačenih jelenov, testiranih na nacionalni ravni med triletnim obdobjem programa spremljanja.
If however certain PSU are not be able to reach the target of 30 animals tested over the three-year period due to the limited size of their cervid population, the sampling of animals belonging to the target groups listed under point 2.4.(a) may continue in larger PSU even after having reached the target of 30 animals tested, with the objective of reaching a total number of up to 3000 farmed and captive cervids, where possible, tested at national level over the three-year period of the monitoring programme;
Vsi izbrani jeleni morajo biti starejši od 12 mesecev.
a Member State having identified fewer than 100 PSU shall, within every PSU, sample all animals belonging to the target groups listed under point 2.4.(a) over the three-year period, with the objective of approaching a total number of up to 3000 farmed and captive cervids, where possible, tested at national level over the three-year period of the monitoring programme.
Starost se oceni na podlagi rasti in razvoja zob, očitnih znakov odraslosti ali drugih zanesljivih informacij.
for wild and semi-domesticated cervids:
Jeleni morajo biti izbrani iz naslednjih ciljnih skupin:
a Member State having selected 100 PSU shall, within every selected PSU, sample all animals belonging to the target groups listed under point 2.4.(b), over the three-year period until a target of 30 animals tested per PSU is reached, with the objective of reaching up to 3000 wild and semi-domesticated cervids tested at national level over the three-year period;
poginuli/izločeni gojeni jeleni ali jeleni v ujetništvu, opredeljeni kot gojeni jeleni ali jeleni v ujetništvu, ki so bili najdeni mrtvi na zaprtem območju, znotraj katerega so se gojili, med prevozom ali v klavnici, ter gojeni jeleni ali jeleni v ujetništvu, ki so bili pokončani zaradi zdravja ali starosti;
a Member State having identified fewer than 100 PSU shall, within every PSU, sample all animals belonging to the target groups listed under point 2.4.(b) over the three-year period, with the objective of approaching a total number of 3000 wild and semi-domesticated cervids tested at national level over the three-year period of the monitoring programme.
gojeni jeleni ali jeleni v ujetništvu s kliničnimi/bolezenskimi znaki, opredeljeni kot gojeni jeleni ali jeleni v ujetništvu, ki kažejo nenormalne vedenjske znake in/ali lokomotorne motnje in/ali so na splošno v slabem stanju;
All cervids selected must be over 12 months of age.
zaklani gojeni jeleni, ki so bili ocenjeni kot neprimerni za prehrano ljudi;
The age shall be estimated on the basis of dentition, obvious signs of maturity, or any other reliable information.
zaklani gojeni jeleni, ki so bili ocenjeni kot primerni za prehrano ljudi, če je država članica opredelila manj kot 3000 gojenih jelenov in jelenov v ujetništvu iz skupin od (i) do (iii);
The cervids must be selected from the following target groups:
poginuli/izločeni divji jeleni ali delno udomačeni jeleni, opredeljeni kot jeleni, ki so bili najdeni mrtvi v divjini, ter delno udomačeni jeleni, ki so bili najdeni mrtvi ali pokončani zaradi zdravja ali starosti;
fallen/culled farmed or captive cervids, defined as farmed or captive cervids found dead on the enclosed territory in which they are kept, during transport or at slaughterhouse, as well as farmed or captive cervids killed for health/age reasons;
jeleni, ki so bili poškodovani ali ubiti na cesti ali ki jih je poškodoval ali ubil plenilec, opredeljeni kot divji jeleni ali delno udomačeni jeleni, ki jih je zadelo cestno vozilo ali vlak ali so jih napadli plenilci;
clinical/sick farmed or captive cervids, defined as farmed or captive cervids showing abnormal behavioural signs and/or locomotor disturbances and/or as being generally in poor condition;
divji jeleni ali delno udomačeni jeleni s kliničnimi/bolezenskimi znaki, opredeljeni kot divji jeleni ali delno udomačeni jeleni, ki kažejo nenormalne vedenjske znake in/ali lokomotorne motnje in/ali so na splošno v slabem zdravstvenem stanju;
slaughtered farmed cervids which have been declared unfit for human consumption;
uplenjeni divji jeleni in zaklani delno udomačeni jeleni, ki so bili ocenjeni kot neprimerni za prehrano ljudi;
slaughtered farmed cervids considered fit for human consumption if a Member State identifies fewer than 3000 farmed and captive cervids from the groups (i) to (iii).
uplenjena divjad in zaklani delno udomačeni jeleni, ki so bili ocenjeni kot primerni za prehrano ljudi, če je država članica opredelila manj kot 3000 divjih jelenov in delno udomačenih jelenov iz skupin od (i) do (iv).
fallen/culled wild or semi-domesticated cervids, defined as cervids found dead in the wild as well as semi-domesticated cervids found dead or killed for health/age reasons;
V primeru pozitivnega testa na TSE pri jelenu je treba povišati število vzorcev, ki se odvzamejo jelenom na območju, kjer je bila ugotovljena TSE, na podlagi ocene, ki jo izvede zadevna država članica.
road- or predator-injured or killed cervids, defined as wild or semi-domesticated cervids hit by road vehicles, by trains or attacked by predators;
Vzorčenje in laboratorijsko testiranje
clinical/sick wild and semi-domesticated cervids, defined as wild and semi-domesticated cervids which are observed as showing abnormal behavioural signs and/or locomotor disturbances and/or as being generally in poor health condition;
Pri vsakem jelenu, izbranem v skladu s točko 2, se odvzame vzorec obeksa in testira na TSE.
wild hunted cervids and slaughtered semi-domesticated cervids which have been declared unfit for human consumption;
Poleg tega se, kadar je to mogoče, odvzame vzorec enega od naslednjih tkiv po naslednjem prednostnem vrstnem redu:
hunted wild game and slaughtered semi-domesticated cervids considered fit for human consumption if a Member State identifies fewer than 3000 wild and semi-domesticated cervids from the groups (i) to (iv).
retrofaringealne bezgavke;
In case of a positive finding of TSE in a cervid, the number of samples from cervids collected in the zone where the positive TSE case was found must be increased, based on an assessment carried out by the Member State concerned.
tonzile;
Sampling and laboratory testing
druge bezgavke na glavi.
For each cervid selected in accordance with point 2, a sample of obex shall be collected and tested for TSEs.
Za hitro testiranje se predloži hemisekcija obeksa v svežem ali zamrznjenem stanju.
In addition, where feasible, a sample of one of the following tissues shall be collected in the following order of preference:
Preostalo hemisekcijo je treba fiksirati.
retropharyngeal lymph nodes;
Po odvzemu je treba bezgavke in tonzile fiksirati.
tonsils;
Do pridobitve negativnega rezultata se shrani del svežega tkiva iz vsake vrste vzorca v zamrznjenem stanju, če bi bil potreben biološki preskus.
other head lymph nodes.
Dokler referenčni laboratorij EU za TSE ne objavi smernic za testiranje jelenov na TSE, se v okviru programa spremljanja bolezni kroničnega hiranja uporablja naslednja laboratorijska metoda:
For rapid testing a hemisection of obex shall be submitted in a fresh or frozen state.
hitri testi:
The remaining hemisection should be fixed.
hitri testi iz točke 4 poglavja C Priloge X, ki se uporabljajo za ugotavljanje TSE v obeksu govedi ali drobnice, se štejejo kot primerni za ugotavljanje TSE v obeksu jelenov.
When collected, lymph nodes and tonsils should be fixed.
Hitri testi iz točke 4 poglavja C Priloge X, ki se uporabljajo za ugotavljanje TSE v bezgavkah govedi ali drobnice, se štejejo kot primerni za ugotavljanje TSE v bezgavkah jelenov.
A portion of fresh tissue from each sample type shall be kept frozen until a negative result is obtained, in case bioassay is required.
Države članice lahko za namene naključnega preverjanja uporabijo tudi imunohistokemijo, za katero morajo zadostiti preskusu usposobljenosti, ki ga organizira referenčni laboratorij EU za TSE;
Until the publication of guidelines on TSE testing in cervids of the EU Reference Laboratory for TSE, the following laboratory method shall be used for the purpose of the CWD monitoring programme:
potrditveni testi:
rapid tests:
Če rezultat hitrega testa ni dokončen ali je pozitiven, se na vzorcu opravijo potrditvene preiskave z uporabo vsaj ene od naslednjih metod in protokolov iz zadnje izdaje Priročnika diagnostičnih testov in cepiv za kopenske živali Svetovne organizacije za zdravje živali (OIE):
Rapid tests as referred to in point 4 of Chapter C of Annex X used for TSE detection in obex of bovine or small ruminant animals are considered suitable for TSE detection in obex of cervids.
imunohistokemijska metoda (IHC);
Rapid tests as referred to in point 4 of Chapter C of Annex X used for TSE detection in the lymph nodes of bovine or small ruminant animals are considered suitable for TSE detection in lymph nodes of cervids.
Kadar država članica ne more potrditi pozitivnega rezultata hitrega testa, pošlje ustrezno tkivo referenčnemu laboratoriju EU v potrditev;
Member States may also use immunohistochemistry for screening purposes for which purpose they shall satisfy a proficiency test organised by the EU Reference Laboratory for TSE.
karakterizacija izolata:
confirmatory tests:
V primeru pozitivnega testa na TSE je treba ob posvetovanju z referenčnim laboratorijem EU za TSE opraviti dodatno karakterizacijo izolata.
the immunohistochemical (IHC) method;
Poleg tega se pri vsakem jelenu, ki je bil testiran z negativnim rezultatom na TSE, bodisi:
Western blot.
določi genotip prionskega proteina živali, testirane z negativnim rezultatom na TSE, ali
Where a Member State is unable to confirm a positive rapid test result, it shall send adequate tissue to the EU Reference laboratory for confirmation.
se vzorec tkiva, ki je lahko obeks, hrani zamrznjen vsaj do 31. decembra 2021, da se omogoči genotipizacija, če bo tako odločeno.
isolate characterisation:
B. Drugo spremljanje pri jelenih
In the case of positive findings of TSE, further isolate characterisation should be undertaken, in consultation with the EU Reference Laboratory for TSE.
Države članice izvajajo dodatno spremljanje TSE pri jelenih na podlagi ocene tveganja, ki lahko upošteva ugotovitev TSE pri jelenih v istih ali sosednjih regijah.
The prion protein genotype shall be determined for each positive finding of TSE in cervids.
Države članice, ki niso navedene v točki 1.1 dela A, lahko prostovoljno spremljajo TSE pri jelenih.
In addition, for each cervid tested and found negative for TSE, either:
Ob koncu triletnega programa spremljanja iz dela A lahko države članice, navedene v točki 1.1, izvajajo prostovoljno spremljanje TSE pri jelenih.“
the prion protein genotype of the animal tested and found negative for TSE is determined, or
v poglavju A se doda naslednji del IV:
a sample of a tissue, which may be the obex, shall be kept frozen until at least 31 December 2021, to allow for genotyping if so decided.
SPREMLJANJE DRUGIH ŽIVALSKIH VRST
B. Other monitoring in cervids
Države članice lahko prostovoljno spremljajo TSE pri drugih živalskih vrstah, ne samo pri govedu, ovcah, kozah in jelenih.“
Member States shall carry out additional monitoring for TSEs in cervids based on a risk assessment which may take into account the detection of a TSE in cervids in the same or neighbouring regions.
v delu I.(A) poglavja B se točka 7 nadomesti z naslednjim:
Member States other than those mentioned under point 1.1 of Part A may on a voluntary basis carry out monitoring for TSEs in cervids.
Pri živalih, razen pri govedu, ovcah in kozah, ter pri jelenih, ki niso zajeti s triletnim programom spremljanja bolezni kroničnega hiranja iz dela III.A poglavja A te priloge, število vzorcev in potrjenih primerov TSE za vsako vrsto.“
After the end of the three-year monitoring programme referred to in Part A, the Member States mentioned under point 1.1 may on a voluntary basis carry out monitoring for TSEs in cervids.’
v delu I.(A) poglavja B se doda naslednja točka 9:
In Chapter A, the following Part IV is added:
Za države članice, zajete v triletni program spremljanja bolezni kroničnega hiranja iz dela III.A poglavja A te priloge, letna poročila za leta 2018, 2019 in 2020 vključujejo:
MONITORING IN OTHER ANIMAL SPECIES
število vzorcev jelenov, danih na testiranje, za vsako ciljno skupino v skladu z naslednjimi merili:
Member States may on a voluntary basis carry out monitoring for TSE in animal species other than bovine, ovine, caprine and cervid animals.’
identifikator primarne enote vzorčenja,
In Chapter B, Part I.(A), point 7 is replaced by the following:
vrsta,
In animals other than bovine, ovine and caprine animals, as well as in cervids other than those covered by the three-year CWD monitoring programme referred to in Part III.A of Chapter A of this Annex, the number of samples and confirmed TSE cases per species.’
sistem upravljanja, gojeni, v ujetništvu, divji ali delno udomačeni,
In Chapter B, Part I.(A), the following point 9 is added:
ciljna skupina,
For Member States covered by the three-year CWD monitoring programme referred to in Part III.A of Chapter A of this Annex, the annual report for the years 2018, 2019 and 2020 shall include:
spol;
The number of cervid samples submitted for testing, by target group according to the following criteria:
rezultate hitrih in potrditvenih testov (število pozitivnih in negativnih rezultatov) ter, kjer je to primerno, preiskav nadaljnjih karakterizacij izolatov, vzorčeno tkivo in tehniko, uporabljeno pri hitrih in potrditvenih testih;
primary Sampling Unit (PSU) identifier,
geografski položaj pozitivnih primerov TSE, vključno z državo porekla, če ta ni ista kot država članica poročevalka;
species,
genotip in vrsto vsakega jelena s pozitivnim rezultatom testa na TSE;
management system: farmed, captive, wild or semi-domesticated,
genotip jelenov, testiranih z negativnim rezultatom testa na TSE, kadar je bil genotip določen.“
target group,
Bolezen kroničnega hiranja je transmisivna spongiformna encefalopatija, ki prizadene jelene in je razširjena v Severni Ameriki.
sex,
Bolezen do danes še ni bila prijavljena na ozemlju Unije, vendar je bila leta 2016 prvič odkrita pri severnem jelenu na Norveškem.
The results of the rapid and confirmatory tests (number of positives and negatives) and, where applicable, of further isolate characterisation investigations, the tissue sampled and the rapid test and confirmatory technique used.
Odločba Komisije 2007/182/ES [3] določa zahteve za raziskavo v zvezi z boleznijo kroničnega hiranja pri jelenih, ki je bila opravljena med letoma 2007 in 2010.
The geographical location, including the country of origin if not the same as the reporting Member State, of positive cases of TSE.
Ker je bila ta raziskava zaključena in da bi se izognili različnim opredelitvam, relevantnim za spremljanje bolezni kroničnega hiranja, iz Priloge I k navedeni odločbi in iz te uredbe, bi bilo treba Odločbo 2007/182/ES razveljaviti.