natgillin/translations-raw huggingface dataset:
As regards the size of the quarantined epidemiological units, a minimum size eligible for certification for negative diagnostic test results should be specified due to the limited sensitivity of the best available real-time quantitative polymerase chain reaction (qPCR) assay which is sufficiently reliable to be used only if the epidemiological units comprise at least 62 salamanders.
Stoga bi se na sve pošiljke daždevnjaka namijenjenih trgovini unutar Unije ili unesenih u Uniju trebale primjenjivati mjere za smanjenje rizika.
Salamanders which have undergone quarantine with testing with negative results or satisfactory treatment in the Union should not be subjected to quarantine or testing again, provided that they have been kept isolated from salamanders of a different health status in an appropriate establishment.
Za ustanove u kojima će se daždevnjaci držati u karanteni trebalo bi utvrditi minimalne uvjete biosigurnosti, a s daždevnjacima koji uginu u tim ustanovama trebalo bi postupati u skladu s postojećim posebnim pravilima utvrđenima Uredbom o nusproizvodima životinjskog podrijetla.
As regards treatments, these should be specified and be in line with the protocols already described in peer-reviewed scientific literature as highlighted by the EFSA Assistance or with comparable ones.
Kad je riječ o veličini epidemioloških jedinica u karanteni, trebalo bi odrediti najmanju prihvatljivu veličinu za izdavanje certifikata o dijagnostičkom testiranju s negativnim rezultatima zbog ograničene osjetljivosti najboljeg dostupnog testa kvantitativnom lančanom reakcijom polimeraze u stvarnom vremenu (qPCR) koji je dovoljno pouzdan za primjenu samo ako se epidemiološke jedinice sastoje od najmanje 62 daždevnjaka.
A list of third countries approved for issuing animal health certificates for the introduction into the Union of consignments of salamanders should be established and limited to those countries which have already provided sufficient guarantees for issuing certificates to prevent misleading and fraudulent certification, at least equivalent to Council Directive 96/93/EC.
Na daždevnjake koji su prošli karantenu uz testiranje s negativnim rezultatima ili su zadovoljavajuće liječeni u Uniji ne bi trebalo ponovno primjenjivati karantenu ili testiranje, pod uvjetom da su u odgovarajućoj ustanovi bili izolirani od daždevnjaka s drukčijim zdravstvenim statusom.
Therefore, it is appropriate to refer to already available lists existing in the context of introduction into the Union of other commodities.
Kad je riječ o liječenju, ono bi trebalo biti točno određeno i u skladu s protokolima koji su već opisani u stručno ocijenjenoj znanstvenoj literaturi kako je istaknuto u okviru izvješća EFSA-e o pomoći ili u skladu s usporedivim protokolima.
Such third countries are listed in Annex I to Commission Decision 2004/211/EC, Part 2 of Annex II to Commission Decision 2007/777/EC, Annex I to Commission Regulation (EC) No 798/2008, Part 1 of Annex I to Commission Regulation (EC) No 119/2009, Part 1 of Annex II to Commission Regulation (EU) No 206/2010, or Annex I to Commission Regulation (EU) No 605/2010, respectively.
Trebalo bi utvrditi popis trećih zemalja kojima je odobreno izdavanje certifikata o zdravlju životinja za unošenje pošiljaka daždevnjaka u Uniju te ga ograničiti na one zemlje koje su već pružile dostatna jamstva za izdavanje certifikata radi sprečavanja obmanjujućeg ili lažnog izdavanja certifikata, koja su u najmanjoj mjeri jednakovrijedna onima iz Direktive Vijeća 96/93/EZ.
Consignments of salamanders should be introduced in the Union only if they comply with all the requirements and the competent veterinary authority of the border inspection post of entry can also ascertain that the consignments will be accepted by an operator responsible for an appropriate establishment of destination to be duly quarantined.
Stoga je primjereno uputiti na već dostupne popise koji postoje u kontekstu unošenja drugih roba u Uniju.
The actual arrival of consignments of salamanders introduced into the Union from third countries at their place of quarantine in the Union should be recorded in the electronic version of the common veterinary entry document set out in Annex I to Commission Regulation (EC) No 282/2004 and managed by the integrated computerised veterinary system known as Traces, so that the competent veterinary authority of the border inspection post of entry can be reliably informed of their arrival.
Te treće zemlje navedene su u Prilogu I.
This Decision should provide for a transitional period in order to give the Member States, the competent authorities and economic operators time to put in place the necessary procedures so that they are in a position to comply with the rules laid down in this Decision.
Odluci Komisije 2004/211/EZ, dijelu 2.
The length of this period should be limited to a few months.
Priloga II.
At the same time, risk mitigation measures based on the required level of protection by the Member States of destination should already apply.
Odluci Komisije 2007/777/EZ, Prilogu I. Uredbi Komisije (EZ) br. 798/2008, dijelu 1.
It is expected that more information will be available in the coming years about Bsal from scientific sources and from results of official controls carried out by the Member States, supplementing the current knowledge concerning that disease.
Priloga I. Uredbi Komisije (EZ) br. 119/2009, dijelu 1.
Therefore, the animal health protection measures laid down in this Decision should be of a temporary nature.
Priloga II.
Nevertheless, they should apply at least until 31 December 2019 to allow for 1 year of implementation by the Member States and subsequent annual reporting and consideration thereof, while permanent EU animal health rules may be laid down under the new Regulation (EU) 2016/429 on transmissible animal diseases to apply from the date of application of that Regulation.
Uredbi Komisije (EU) br. 206/2010 ili Prilogu I. Uredbi Komisije (EU) br. 605/2010.
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Pošiljke daždevnjaka trebale bi se unositi u Uniju samo ako su u skladu sa svim zahtjevima te ako nadležno veterinarsko tijelo granične inspekcijske postaje ulaska može utvrditi i da će pošiljke prihvatiti subjekt odgovoran za odgovarajuću ustanovu odredišta u kojoj će ih propisno staviti u karantenu.
HAS ADOPTED THIS DECISION:
Stvarno prispijeće pošiljaka daždevnjaka unesenih u Uniju iz trećih zemalja na njihovo mjesto karantene u Uniji trebalo bi evidentirati u elektroničkoj verziji zajedničkog veterinarskog dokumenta o ulasku utvrđenog u Prilogu I. Uredbi Komisije (EZ) br. 282/2004, kojim se upravlja u okviru integriranog računalnog veterinarskog sustava poznatog kao TRACES, kako bi se nadležno veterinarsko tijelo granične inspekcijske postaje ulaska moglo pouzdano obavijestiti o njihovu prispijeću.
Article 1
Ovom bi se Odlukom trebalo predvidjeti prijelazno razdoblje kako bi države članice, nadležna tijela i gospodarski subjekti imali dovoljno vremena za uvođenje potrebnih postupaka kako bi se mogli uskladiti s pravilima utvrđenima ovom Odlukom.
Subject and scope
Trajanje tog razdoblja trebalo bi ograničiti na nekoliko mjeseci.
This Decision lays down the animal health protection measures for intra-Union trade in consignments of salamanders and the introduction of such consignments into the Union.
Istodobno bi se već trebale primjenjivati mjere za smanjenje rizika koje se temelje na razini zaštite koju zahtijevaju države članice odredišta.
Article 2
Očekuje se da će u idućim godinama biti dostupno više informacija o gljivici Bsal iz znanstvenih izvora i iz rezultata službenih kontrola koje provode države članice, čime će se dopuniti postojeće spoznaje o toj bolesti.
Definitions
Stoga bi mjere za zaštitu zdravlja životinja utvrđene ovom Odlukom trebale biti privremene.
For the purposes of this Decision, the following definitions shall apply:
Unatoč tome, one bi se trebale primjenjivati barem do 31. prosinca 2019. kako bi se državama članicama omogućila jedna godina provedbe te popratno godišnje izvješćivanje o njima i njihovo razmatranje, dok se stalna pravila EU-a o zdravlju životinja mogu utvrditi na temelju nove Uredbe (EU) 2016/429 o prenosivim bolestima životinja koja će se primjenjivati od datuma početka primjene te uredbe.
‘salamanders’ means all amphibians of the order Caudata;
Mjere predviđene ovom Odlukom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
‘Bsal’ means the fungus Batrachochytrium salamandrivorans (kingdom fungi, Phylum Chytridiomycota, order Rhizophydiales);
DONIJELA JE OVU ODLUKU:
‘epidemiological unit’ means a group of salamanders with the same likelihood of exposure to Bsal;
Članak 1.
‘quarantine’ means the keeping of salamanders in isolation with no direct or indirect contact with salamanders outside their epidemiological unit, for the purposes of ensuring that there is no spread of Bsal while the animals in isolation are undergoing observation for a specified length of time and testing and, if appropriate, treatment;
Predmet i područje primjene
‘operator’ means any natural or legal person having salamanders under its responsibility, including for a limited duration of time, but excluding pet keepers;
Ovom se Odlukom utvrđuju mjere za zaštitu zdravlja životinja za trgovinu pošiljkama daždevnjaka unutar Unije i unošenje tih pošiljaka u Uniju.
‘appropriate establishment’ means premises:
Članak 2.
where salamanders are kept in quarantine before being dispatched to another Member State or after their introduction into the Union; and
Definicije
which are registered by the competent authority prior to the date of commencement of any quarantine;
Za potrebe ove Odluke primjenjuju se sljedeće definicije:
‘appropriate diagnostic test’ means a real-time quantitative polymerase chain reaction (qPCR) assay containing species-specific STerF and STerR primers amplifying a 119 nucleotide long fragment of Bsal DNA;
„daždevnjaci” znači svi vodozemci iz reda Caudata;
‘common veterinary entry document’ or ‘CVED’ means the document notifying the arrival of animals into the Union as provided for in Article 1 of Regulation (EC) No 282/2004 and drawn up in accordance with the model set out in Annex I thereto and managed by the integrated computerised veterinary system known as Traces;
„Bsal” znači gljivica Batrachochytrium salamandrivorans (carstvo gljiva, koljeno Chytridiomycota, red Rhizophydiales);
‘confirmed case of Bsal’ means the confirmation of the presence of Bsal or its genetic material on or in the tissues of salamanders by the appropriate diagnostic test;
„epidemiološka jedinica” znači skupina daždevnjaka koji su vjerojatno jednako izloženi gljivici Bsal;
Article 3
„karantena” znači držanje daždevnjaka u izolaciji, bez izravnog ili neizravnog kontakta s daždevnjacima izvan te epidemiološke jedinice, kako bi se osiguralo da ne dođe do širenja gljivice Bsal dok su izolirane životinje na promatranju tijekom određenog razdoblja i na testiranju te, ako je potrebno, dok su na liječenju;
Animal health conditions for intra-Union trade in salamanders
„subjekt” znači svaka fizička ili pravna osoba koja je odgovorna za daždevnjake, između ostalog u ograničenom razdoblju, izuzev držatelja kućnih ljubimaca;
Member States shall prohibit the dispatch of consignments of salamanders to another Member State, except where such consignments comply with the following animal health conditions:
„odgovarajuća ustanova” znači prostorije:
they are accompanied by an animal health certificate which complies with the model animal health certificate set out in Part A of Annex I;
i. u kojima se daždevnjaci drže u karanteni prije otpremanja u drugu državu članicu ili nakon njihova unošenja u Uniju; i
the salamanders must not show clinical signs of Bsal, in particular they must show no skin lesions and ulcers at the time of examination by the official veterinarian; that examination must be carried out within a period of 24 hours prior to the time of dispatch of the consignment to the Member State of destination;
koje je nadležno tijelo registriralo prije datuma početka bilo koje karantene;
the salamanders must come from a population where there have been no mortalities due to Bsal and no clinical signs of Bsal, in particular skin lesions and ulcers must not have been observed by the operator;
„odgovarajući dijagnostički test” znači test lančanom reakcijom polimeraze u stvarnom vremenu (qPCR) koji sadržava početnice STerF i STerR specifične za vrstu kojima se umnožava DNK fragment gljivice Bsal dug 119 nukleotida;
the consignment must consist of:
„zajednički veterinarski dokument o ulasku” ili „ZVDU” znači dokument kojim se prijavljuje prispijeće životinja u Uniju kako je predviđeno člankom 1.
at least 62 salamanders which have undergone quarantine as one epidemiological unit in an appropriate establishment which complies with the minimum conditions set out in Annex II for a period of at least 6 weeks immediately prior to the date of the issuing of the animal health certificate set out in Part A of Annex I and skin swab samples from the salamanders in the consignment must have been tested for Bsal with negative results during the fifth week of the period of quarantine with the appropriate diagnostic test, in accordance with the sample sizes set out in point 1(a) of Annex III; or
Uredbe (EZ) br. 282/2004 i koji je sastavljen u skladu s obrascem utvrđenim u Prilogu I. toj uredbi te kojim se upravlja u okviru integriranog računalnog veterinarskog sustava poznatog kao TRACES;
salamanders which have been treated to the satisfaction of the competent authority against Bsal in accordance with point 1(b) of Annex III.
„potvrđeni slučaj gljivice Bsal” znači potvrda prisutnosti gljivice Bsal ili njezina genetskog materijala na ili u tkivima daždevnjaka primjenom odgovarajućeg dijagnostičkog testa.
Where consignments of salamanders have been introduced into the Union from a third country and they have already undergone quarantine in an appropriate establishment of destination in accordance with Article 6, Member States shall only authorise their dispatch to another Member State where such consignments comply with the following conditions:
Članak 3.
the animal health conditions laid down in paragraph 1(a), (b) and (c);
Uvjeti zdravlja životinja za trgovinu daždevnjacima unutar Unije
the salamanders have been kept in quarantine in the appropriate establishment which complies with the minimum conditions set out in Annex II, between the end of the period of quarantine following their introduction into the Union and the issuing of the animal health certificate set out in Part A of Annex I.
Države članice moraju zabraniti otpremanje pošiljaka daždevnjaka u drugu državu članicu, osim ako su te pošiljke u skladu sa sljedećim uvjetima zdravlja životinja:
Article 4
pošiljke imaju certifikat o zdravlju životinja koji je u skladu s obrascem certifikata o zdravlju životinja utvrđenim u dijelu A Priloga I.;
Animal health conditions for the introduction into the Union of consignments of salamanders
daždevnjaci ne smiju pokazivati kliničke znakove gljivice Bsal, posebno ne smiju pokazivati znakove lezija kože ni čireva u trenutku ispitivanja koje provodi službeni veterinar; to ispitivanje mora se provesti u roku od 24 sata prije trenutka otpremanja pošiljke u državu članicu odredišta;
Member States shall prohibit the introduction into the Union of consignments of salamanders from a third country, except where such consignments comply with the following conditions:
daždevnjaci moraju potjecati iz populacije u kojoj nije bilo uginuća zbog gljivice Bsal ni kliničkih znakova gljivice Bsal te je posebno nužno da subjekt nije primijetio lezije kože ni čireve;
they come from third countries listed in one of the following:
pošiljka se mora sastojati od:
Annex I to Decision 2004/211/EC;
i. najmanje 62 daždevnjaka koji su prošli karantenu kao jedna epidemiološka jedinica u odgovarajućoj ustanovi koja je u skladu s minimalnim uvjetima utvrđenima u Prilogu II. tijekom razdoblja od najmanje šest tjedana neposredno prije datuma izdavanja certifikata o zdravlju životinja utvrđenog u dijelu A Priloga I. te su uzorci brisova kože daždevnjaka iz pošiljke morali biti testirani na gljivicu Bsal s negativnim rezultatima tijekom petog tjedna razdoblja karantene primjenom odgovarajućeg dijagnostičkog testa, u skladu s veličinama uzoraka utvrđenima u točki 1. podtočki (a) Priloga III.; ili
Part 2 of Annex II to Decision 2007/777/EC;
daždevnjaka koji su liječeni od gljivice Bsal postupcima koje nadležno tijelo smatra zadovoljavajućima u skladu s točkom 1. podtočkom (b) Priloga III.
Annex I to Regulation (EC) No 798/2008;
Ako su pošiljke daždevnjaka unesene u Uniju iz treće zemlje te su već prošle karantenu u odgovarajućoj ustanovi odredišta u skladu s člankom 6., države članice odobravaju njihovo otpremanje u drugu državu članicu samo ako su te pošiljke u skladu sa sljedećim uvjetima:
Part 1 of Annex I to Regulation (EC) No 119/2009;
ispunjeni su uvjeti zdravlja životinja utvrđeni u stavku 1. točkama (a), (b) i (c);
Part 1 of Annex II to Regulation (EU) No 206/2010;
daždevnjaci su držani u karanteni u odgovarajućoj ustanovi koja je u skladu s minimalnim uvjetima utvrđenima u Prilogu II. u razdoblju od kraja razdoblja karantene nakon njihova unošenja u Uniju do izdavanja certifikata o zdravlju životinja utvrđenoga u dijelu A Priloga I.
Annex I to Regulation (EU) No 605/2010;
Članak 4.
they are accompanied by an animal health certificate which complies with the model animal health certificate set out in Part B of Annex I;
Uvjeti zdravlja životinja za unošenje pošiljaka daždevnjaka u Uniju
the salamanders must not show clinical signs of Bsal, in particular there must be no signs of skin lesions and ulcers at the time of examination by the official veterinarian; and that examination must have been carried out within a period of 24 hours prior to the time of dispatch of the consignment to the Union;
Države članice moraju zabraniti unošenje pošiljaka daždevnjaka iz treće zemlje u Uniju, osim ako su te pošiljke u skladu sa sljedećim uvjetima:
before issuing the animal health certificate referred to in point (b), the epidemiological unit comprising the salamanders in the consignment must have been isolated from other salamanders at the latest at the time of the examination for the purposes of issuing of animal health certificate and they must not have been in contact with other salamanders since that time.
pošiljke potječu iz trećih zemalja navedenih u jednom od sljedećih propisa: i.
Article 5
Prilog I.
Attestation regarding the appropriate establishment of destination
Odluci 2004/211/EZ;
Member States shall ensure that border inspection posts do not accept the entry into the Union of consignments of salamanders unless importers or their agents provide a written attestation, in an official language of the Member State of the border inspection post of entry into the Union, which is signed by the natural or legal person responsible for the appropriate establishment of destination, stating:
dio 2.
the name and address of the appropriate establishment of destination;
Priloga II.
that the appropriate establishment of destination complies with the minimum conditions set out in Annex II;
Odluci 2007/777/EZ;
that the consignment of salamanders will be accepted for quarantine.
iii.
Article 6
Prilog I. Uredbi (EZ) br. 798/2008;
Quarantine rules for consignments of salamanders introduced into the Union
dio 1.
Member States shall ensure that:
Priloga I. Uredbi (EZ) br. 119/2009;
The official or approved veterinarian responsible for the appropriate establishment of destination records the arrival of the consignment of salamanders introduced into the Union from a third country in Box 45 of Part 3 in the electronic version of the common veterinary entry document.
v. dio 1.
The official or approved veterinarian ensures that the operator keeps the consignment of salamanders in quarantine in the appropriate establishment of destination as one epidemiological unit.
Priloga II.
The official or approved veterinarian inspects the conditions of quarantine for each consignment of salamanders, including an examination of the mortality records and a clinical inspection of the salamanders in the appropriate establishment of destination, checking in particular for skin lesions and ulcers.
vi.
Where a consignment comprises 62 or more salamanders, the official or approved veterinarian carries out the examination, sampling, testing and treatment procedures for Bsal in accordance with the procedures referred to in points 1 and 2 of Annex III, following the arrival of the consignment of salamanders at the appropriate establishment of destination.
Prilog I. Uredbi (EU) br. 605/2010;
Where the consignment comprises less than 62 salamanders, the official or approved veterinarian ensures that the consignment is treated to the satisfaction of the competent authority against Bsal in accordance with point 3 of Annex III.
pošiljke imaju certifikat o zdravlju životinja koji je u skladu s obrascem certifikata o zdravlju životinja utvrđenim u dijelu B Priloga I.;
The official or approved veterinarian releases the consignment of salamanders from the appropriate establishment of destination by a written authorisation:
daždevnjaci ne smiju pokazivati kliničke znakove gljivice Bsal, posebno ne smije biti znakova lezija kože ni čireva u trenutku ispitivanja koje provodi službeni veterinar; to ispitivanje moralo se provesti u roku od 24 sata prije trenutka otpremanja pošiljke u Uniju;
in case of testing as referred to in point 1(a) of Annex III, provided that at least 6 weeks has elapsed since the date of the the commencement of the period of quarantine and not before the receipt of the negative test results, whichever is later; or
prije izdavanja certifikata o zdravlju životinja iz točke (b) epidemiološka jedinica koja se sastoji od daždevnjaka iz pošiljke morala je biti izolirana od drugih daždevnjaka najkasnije u trenutku ispitivanja za potrebe izdavanja certifikata o zdravlju životinja te oni od tog trenutka nisu smjeli biti u kontaktu s drugim daždevnjacima.
in the case of treatment as referred to in point 1(b) of Annex III, only after satisfactory completion of the treatment.
Članak 5.
Article 7
Potvrda o odgovarajućoj ustanovi odredišta
Measures to be taken in the event of a confirmed case of Bsal in an appropriate establishment of destination
Države članice moraju se pobrinuti da granične inspekcijske postaje ne prihvate ulazak pošiljaka daždevnjaka u Uniju, ako uvoznici ili njihovi zastupnici ne predoče pisanu potvrdu na službenom jeziku države članice u kojoj se nalazi granična inspekcijska postaja ulaska u Uniju, koju je potpisala fizička ili pravna osoba odgovorna za odgovarajuću ustanovu odredišta i u kojoj se navodi:
Member States shall ensure that where during quarantine it is confirmed that at least one salamander of an epidemiological unit is infected with Bsal, the following measures are taken by the appropriate establishment of destination:
naziv i adresa odgovarajuće ustanove odredišta;
all salamanders in the same epidemiological unit are either:
da je odgovarajuća ustanova odredišta u skladu s minimalnim uvjetima utvrđenima u Prilogu II.;
treated to the satisfaction of the competent authority against Bsal in accordance with point 3 of Annex III; or
da će pošiljka daždevnjaka biti primljena u karantenu.
killed and disposed of as animal by-products in accordance with Article 12 of Regulation (EC) No 1069/2009.
Članak 6.
following completion of the measures referred to in point (a), the area of the appropriate establishment of destination where the epidemiological unit had been kept is cleaned and disinfected to the satisfaction of the competent authority.
Pravila o karanteni za pošiljke daždevnjaka unesenih u Uniju
The competent authority may require testing of the treated salamanders to verify the effectiveness of the treatment referred to in point 1(a)(i) and may require repeated treatments, as appropriate, to prevent the spread of Bsal.
Države članice osiguravaju sljedeće.