natgillin/translations-raw huggingface dataset:
points (b)(i) or (c) of Article 5 of this Directive and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of debilitating or potentially life-threatening clinical conditions in human beings; or
točke (b)(i) ali (c) člena 5 te direktive in se izvaja za odvračanje, preprečevanje, diagnosticiranje ali zdravljenje stanj splošne oslabelosti ali potencialno življenje ogrožajočih kliničnih stanj pri človeku; ali
points (a) or (e) of Article 5;
točke (a) ali (e) člena 5;
there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than non-human primates.
obstaja znanstvena utemeljitev, da namena postopka ni mogoče doseči z uporabo živalske vrste, ki niso primati razen človeka.
A debilitating clinical condition for the purposes of this Directive means a reduction in a person’s normal physical or psychological ability to function.
Klinično stanje splošne oslabelosti za namene te direktive pomeni zmanjšanje človekove normalne fizične ali psihološke opravilne sposobnosti.
Specimens of non-human primates listed in Annex A to Regulation (EC) No 338/97, which do not fall within the scope of Article 7(1) of that Regulation, shall not be used in procedures, with the exception of those procedures meeting the following conditions:
Primerki primatov razen človeka iz Priloge A k Uredbi (ES) št. 338/97, ki ne spadajo v področje uporabe člena 7(1) navedene uredbe, se v postopkih ne uporabljajo, z izjemo tistih postopkov, ki izpolnjujejo naslednje pogoje:
the procedure has one of the purposes referred to in:
postopek ima enega od namenov iz
Article 5(e);
točke (e) člena 5;
there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than non-human primates and by the use of species not listed in that Annex.
obstaja znanstvena utemeljitev, da namena postopka ni mogoče doseči z uporabo živalske vrste, ki niso primati razen človeka, in z uporabo živalskih vrst, ki niso naštete v navedeni prilogi.
Notwithstanding paragraphs 1 and 2, great apes shall not be used in procedures, subject to the use of the safeguard clause in Article 55(2).
Ne glede na določbe odstavkov 1 in 2 se velike opice ne uporabljajo v postopkih s pridržkom uporabe zaščitne klavzule iz člena 55(2).
Animals taken from the wild
Živali iz naravnega okolja
Animals taken from the wild shall not be used in procedures.
Živali, odvzetih iz naravnega okolja, se v postopkih ne uporablja.
Competent authorities may grant exemptions from paragraph 1 on the basis of scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of an animal which has been bred for use in procedures.
Pristojni organi lahko odobrijo odstopanja od odstavka 1 na podlagi znanstvene utemeljitve, da namena postopka ni mogoče doseči z uporabo živali, ki je bila rejena za uporabo v postopkih.
The capture of animals in the wild shall be carried out only by competent persons using methods which do not cause the animals avoidable pain, suffering, distress or lasting harm.
Ulov živali v naravnem okolju se izvaja le s strani kompetentne osebe z uporabo metod, ki tem živalim ne povzročajo izogibnih bolečin, trpljenja, stiske ali trajnih poškodb.
Any animal found, at or after capture, to be injured or in poor health shall be examined by a veterinarian or another competent person and action shall be taken to minimise the suffering of the animal.
Ob ali po ulovu mora vsako poškodovano ali obolelo žival pregledati veterinar ali druga kompetentna oseba, ter storiti vse potrebno, da čim bolj zmanjša trpljenje živali.
Competent authorities may grant exemptions from the requirement of taking action to minimise the suffering of the animal if there is scientific justification.
Pristojni organi lahko dovolijo odstopanja od zahteve, da je treba storiti vse potrebno, da se kar najbolj zmanjša trpljenje živali, če za njeno opustitev obstaja znanstvena utemeljitev.
Animals bred for use in procedures
Živali, ki se vzrejajo za uporabo v postopkih
Member States shall ensure that animals belonging to the species listed in Annex I may only be used in procedures where those animals have been bred for use in procedures.
Države članice zagotovijo, da se živali, ki spadajo med živalske vrste navedene v Prilogi I, lahko uporabijo v postopkih samo takrat, kadar so bile vzrejene za uporabo v postopkih.
However, from the dates set out in Annex II, Member States shall ensure that non-human primates listed therein may be used in procedures only where they are the offspring of non-human primates which have been bred in captivity or where they are sourced from self-sustaining colonies.
Vendar pa od datumov, določenih v Prilogi II, države članice zagotovijo, da se primati razen človeka iz te priloge lahko uporabljajo v postopkih pod pogojem, da so potomci primatov razen človeka, vzrejenih v ujetništvu ali živali iz zaprtih vzrejnih kolonij.
For the purposes of this Article a ‘self-sustaining colony’ means a colony in which animals are bred only within the colony or sourced from other colonies but not taken from the wild, and where the animals are kept in a way that ensures that they are accustomed to humans.
Za namene tega člena „zaprta vzrejna kolonija“ pomeni kolonijo, v kateri se živali vzrejajo samo znotraj kolonije ali se pridobivajo iz drugih kolonij, vendar ne iz naravnega okolja, in v kateri se živali gojijo na način, ki zagotavlja njihovo privajenost na stik s človekom.
The Commission shall, in consultation with the Member States and stakeholders, conduct a feasibility study, which shall include an animal health and welfare assessment, of the requirement laid down in the second subparagraph.
V posvetovanju z državami članicami in zainteresiranimi stranmi Komisija izvede študijo izvedljivosti o zahtevi iz drugega pododstavka, ki vključuje oceno zdravja in dobrega počutja živali.
The Commission shall keep under review the use of sourcing non-human primates from self-sustaining colonies and, in consultation with the Member States and stakeholders, conduct a study to analyse the feasibility of sourcing animals only from self-sustaining colonies.
Komisija spremlja pridobivanje primatov razen človeka iz zaprtih vzrejnih kolonij ter v posvetovanju z državami članicami in zainteresiranimi stranmi opravi študijo, v kateri analizira izvedljivost pridobivanja živali le iz zaprtih vzrejnih kolonij.
The study shall be published no later than 10 November 2022.
Študija se objavi najpozneje 10. novembra 2022.
Competent authorities may grant exemptions from paragraph 1 on the basis of scientific justification.
Pristojni organi lahko odobrijo odstopanja od odstavka 1 na podlagi znanstvene utemeljitve.
Stray and feral animals of domestic species
Potepuške in divje živali domačih živalskih vrst
Stray and feral animals of domestic species shall not be used in procedures.
Potepuške in divje živali domačih živalskih vrst se v postopkih ne uporabljajo.
The competent authorities may only grant exemptions from paragraph 1 subject to the following conditions:
Pristojni organi lahko odobrijo le odstopanja od odstavka 1 pod naslednjimi pogoji:
there is an essential need for studies concerning the health and welfare of the animals or serious threats to the environment or to human or animal health; and
obstaja tehtna potreba po izvedbi študij glede zdravja in dobrega počutja teh živali ali glede resnih tveganj za okolje ali za zdravje ljudi ali živali in
there is scientific justification to the effect that the purpose of the procedure can be achieved only by the use of a stray or a feral animal.
obstaja znanstvena utemeljitev, da je namen postopka mogoče doseči le z uporabo potepuške ali divje živali.
Member States shall ensure that procedures are carried out in a user’s establishment.
Države članice zagotovijo, da se postopki izvajajo v ustanovi uporabnika.
The competent authority may grant an exemption from the first subparagraph on the basis of scientific justification.
Pristojni organ lahko odobri odstopanje od prvega pododstavka na podlagi znanstvene utemeljitve.
Procedures may be carried out only within the framework of a project.
Postopki se lahko izvajajo samo v okviru projekta.
Choice of methods
Izbira metod
Without prejudice to national legislation prohibiting certain types of methods, Member States shall ensure that a procedure is not carried out if another method or testing strategy for obtaining the result sought, not entailing the use of a live animal, is recognised under the legislation of the Union.
Države članice brez poseganja v nacionalno zakonodajo, ki prepoveduje določene vrste metod, zagotovijo, da se postopek ne izvaja, če se v zakonodaji Unije priznava druga metoda ali strategija preskušanja za doseganje željenih rezultatov, ki ne vključuje uporabe žive živali.
In choosing between procedures, those which to the greatest extent meet the following requirements shall be selected:
Pri izbiri postopkov se izberejo tisti, ki v največji meri izpolnjujejo naslednje zahteve:
use the minimum number of animals;
uporabljajo najmanjše število živali;
involve animals with the lowest capacity to experience pain, suffering, distress or lasting harm;
vključujejo živali z najmanjšo sposobnostjo občutenja bolečin, trpljenja, stiske ali trajnih poškodb;
cause the least pain, suffering, distress or lasting harm;
povzročajo najmanj bolečin, trpljenja, stiske ali trajnih poškodb,
and are most likely to provide satisfactory results.
in bodo najverjetneje dali zadovoljive rezultate.
Death as the end-point of a procedure shall be avoided as far as possible and replaced by early and humane end-points.
Smrt kot končni rezultat postopka je treba preprečiti, kolikor je le mogoče, in jo nadomestiti s predčasnim in humanim pokončanjem.
Where death as the end-point is unavoidable, the procedure shall be designed so as to:
Če smrti kot končnega rezultata ni mogoče preprečiti, je treba postopek načrtovati tako, da se:
result in the deaths of as few animals as possible; and
povzroči smrt najmanjšega možnega števila živali ter
reduce the duration and intensity of suffering to the animal to the minimum possible and, as far as possible, ensure a painless death.
da se trajanje in intenzivnost trpljenja živali čim bolj zmanjša in se, kolikor je to mogoče, zagotovi neboleča smrt.
Member States shall ensure that, unless it is inappropriate, procedures are carried out under general or local anaesthesia, and that analgesia or another appropriate method is used to ensure that pain, suffering and distress are kept to a minimum.
Države članice zagotovijo, da se postopki izvajajo pod splošno ali lokalno anestezijo, razen če je to neprimerno, in da se uporablja analgezija ali druga ustrezna metoda za zagotovitev, da so bolečine, trpljenje in stiska čim manjši.
Procedures that involve serious injuries that may cause severe pain shall not be carried out without anaesthesia.
Postopki, ki obsegajo hude poškodbe, ki lahko povzročijo hude bolečine, se ne izvajajo brez anestezije.
When deciding on the appropriateness of using anaesthesia, the following shall be taken into account:
Pri odločanju o primernosti uporabe anestezije se upošteva naslednje:
whether anaesthesia is judged to be more traumatic to the animal than the procedure itself; and
ali se ocenjuje, da je anestezija za žival bolj travmatična od samega postopka; in
whether anaesthesia is incompatible with the purpose of the procedure.
ali je anestezija nezdružljiva z namenom postopka.
Member States shall ensure that animals are not given any drug to stop or restrict their showing pain without an adequate level of anaesthesia or analgesia.
Države članice zagotovijo, da se živalim ne dajejo nobena zdravila, ki bi jim preprečevala ali omejevala prikazovanje bolečine, brez ustrezne stopnje anestezije ali analgezije.
In these cases, a scientific justification shall be provided, accompanied by the details of the anaesthetic or analgesic regimen.
V teh primerih se poda znanstvena utemeljitev, skupaj s podrobnostmi o režimu dajanja anestetika ali analgetika.
An animal, which may suffer pain once anaesthesia has worn off, shall be treated with pre-emptive and post-operative analgesics or other appropriate pain-relieving methods provided that it is compatible with the purpose of the procedure.
Žival, ki lahko občuti bolečine, ko anestezija popusti, se zdravi s preventivno in postoperativno analgezijo ali drugimi primernimi metodami za lajšanje bolečin, če je to združljivo z namenom postopka.
As soon as the purpose of the procedure has been achieved appropriate action shall be taken to minimise the suffering of the animal.
Kakor hitro je dosežen namen postopka, je treba storiti vse potrebno, da se čim bolj zmanjša trpljenje živali.
Classification of severity of procedures
Razvrstitev postopkov po težavnosti
Member States shall ensure that all procedures are classified as ‘non-recovery’, ‘mild’, ‘moderate’, or ‘severe’ on a case-by-case basis using the assignment criteria set out in Annex VIII.
Države članice zagotovijo, da se vsi postopki razvrstijo kot „nepovratni“, „blag“, „zmeren“ ali „težaven“ za vsak primer posebej na podlagi meril za razvrščanje iz Priloge VIII.
Subject to the use of the safeguard clause in Article 55(3), Member States shall ensure that a procedure is not performed if it involves severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated.
S pridržkom uporabe zaščitne klavzule iz člena 55(3) države članice zagotovijo, da se postopek ne izvede, če bi povzročil hude bolečine, trpljenje ali stisko, ki so po vsej verjetnosti dolgotrajni in jih ni mogoče olajšati.
Member States shall ensure that an animal already used in one or more procedures, when a different animal on which no procedure has previously been carried out could also be used, may only be reused in a new procedure provided that the following conditions are met:
Države članice zagotovijo, da se žival, ki je že bila uporabljena v enem ali več postopkih, kadar bi bilo mogoče uporabiti drugo žival, na kateri prej ni bil izveden noben postopek, lahko ponovno uporabi v novem postopku samo, če so izpolnjeni naslednji pogoji:
the actual severity of the previous procedures was ‘mild’ or ‘moderate’;
dejanska težavnost prejšnjega postopka je bila „blaga“ ali „zmerna“;
it is demonstrated that the animal’s general state of health and well-being has been fully restored;
dokazano je, da sta splošno zdravstveno stanje in optimalno počutje živali v celoti povrnjena;
the further procedure is classified as ‘mild’, ‘moderate’ or ‘non-recovery’; and
nadaljnji postopek je razvrščen kot „blag“, „zmeren“ ali „nepovraten“; in
it is in accordance with veterinary advice, taking into account the lifetime experience of the animal.
to je v skladu z veterinarskim mnenjem, ki upošteva življenjske izkušnje živali.
In exceptional circumstances, by way of derogation from point (a) of paragraph 1 and after a veterinary examination of the animal, the competent authority may allow reuse of an animal, provided the animal has not been used more than once in a procedure entailing severe pain, distress or equivalent suffering.
V izjemnih okoliščinah in z odstopanjem od točke (a) odstavka 1 lahko pristojni organ po veterinarskem pregledu živali dovoli ponovno uporabo živali pod pogojem, da žival ni bila uporabljena več kot enkrat v postopku, ki je vključeval hude bolečine, stisko ali podobno trpljenje.
End of the procedure
Konec postopka
A procedure shall be deemed to end when no further observations are to be made for that procedure or, as regards new genetically modified animal lines, when the progeny are no longer observed or expected to experience pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle.
Šteje, da je postopek končan, kadar ni več nadaljnjih opažanj za navedeni postopek ali kadar v primeru novih gensko spremenjenih linij živali pri njihovih potomcih ni več zaznati ali se ne pričakuje več, da bodo občutili bolečine, trpljenje, stisko ali trajne poškodbe, enakovredne ali hujše od vboda igle.
At the end of a procedure, a decision to keep an animal alive shall be taken by a veterinarian or by another competent person.
Na koncu postopka odločitev o ohranitvi živali pri življenju odloča veterinar ali druga kompetentna oseba.
An animal shall be killed when it is likely to remain in moderate or severe pain, suffering, distress or lasting harm.
Žival je treba pokončati, kadar obstaja verjetnost, da bo še naprej čutila zmerne ali hude bolečine, trpljenje, stisko ali trajne poškodbe.
Where an animal is to be kept alive, it shall receive care and accommodation appropriate to its state of health.
Kadar se žival ohrani pri življenju, prejme oskrbo in nastanitev, ki sta ustrezni njenemu zdravstvenemu stanju.
Sharing organs and tissues
Izmenjava organov in tkiv
Member States shall facilitate, where appropriate, the establishment of programmes for the sharing of organs and tissues of animals killed.
Države članice po potrebi omogočijo uvedbo programov za izmenjavo organov in tkiv usmrčenih živali.
Setting free of animals and rehoming
Spustitev živali na prostost in vrnitev v domače okolje
Member States may allow animals used or intended to be used in procedures to be rehomed, or returned to a suitable habitat or husbandry system appropriate to the species, provided that the following conditions are met:
Države članice lahko dovolijo vrnitev živali uporabljenih v postopkih ali namenjenih uporabi v postopkih v družinsko okolje ali v primerno naravno okolje ali rejo, primerno za zadevno živalsko vrsto, pod pogojem, da so izpolnjeni naslednji pogoji:
the state of health of the animal allows it;
zdravstveno stanje živali to omogoča;
there is no danger to public health, animal health or the environment; and
žival ne predstavlja nevarnosti za javno zdravje, zdravje živali ali okolje in
appropriate measures have been taken to safeguard the well-being of the animal.
izvedeni so bili ustrezni ukrepi za zaščito optimalnega počutja te živali.
AUTHORISATION
DOVOLJENJE
Requirements for breeders, suppliers and users
Zahteve za rejce, dobavitelje in uporabnike
Authorisation of breeders, suppliers and users
Dovoljenje rejcev, dobaviteljev in uporabnikov
Member States shall ensure that all breeders, suppliers and users are authorised by, and registered with, the competent authority.
Države članice zagotovijo, da vsi rejci, dobavitelji in uporabniki pridobijo dovoljenje in registracijo pri pristojnem organu.
Such authorisation may be granted for a limited period.
Takšno dovoljenje se lahko izda za omejeno obdobje.
Authorisation shall be granted only if the breeder, supplier or user and its establishment is in compliance with the requirements of this Directive.
Dovoljenje se izda le, če rejec, dobavitelj ali uporabnik in njegova ustanova izpolnjujejo zahteve te direktive.
The authorisation shall specify the person responsible for ensuring compliance with the provisions of this Directive and the person or persons referred to in Article 24(1) and in Article 25.
Dovoljenje mora opredeljevati osebo, odgovorno za zagotavljanje skladnosti z določbami te direktive, in osebo ali osebe iz člena 24(1) in člena 25.
Renewal of the authorisation shall be required for any significant change to the structure or the function of an establishment of a breeder, supplier or user that could negatively affect animal welfare.
Obnovo dovoljenja je potrebno pridobiti za vsako večjo spremembo zgradbe ali delovanja ustanove rejca, dobavitelja ali uporabnika, ki bi lahko negativno vplivala na dobro počutje živali.
Member States shall ensure that the competent authority is notified of any changes of the person or persons referred to in paragraph 2.
Države članice zagotavljajo, da je pristojni organ uradno obveščen o vseh spremembah v zvezi z osebo ali osebami iz odstavka 2.
Suspension and withdrawal of authorisation
Začasni umik in preklic dovoljenja
Where a breeder, supplier or user no longer complies with the requirements set out in this Directive, the competent authority shall take appropriate remedial action, or require such action to be taken, or suspend or withdraw its authorisation.
Kadar rejec, dobavitelj ali uporabnik ne izpolnjuje več zahtev iz te direktive, pristojni organ sprejme ustrezne sanacijske ukrepe ali zahteva, da se takšni ukrepi izvedejo, ali začasno umakne ali prekliče njegovo dovoljenje.
Member States shall ensure that, where the authorisation is suspended or withdrawn, the welfare of the animals housed in the establishment is not adversely affected.
Države članice zagotovijo, da začasni umik ali preklic dovoljenja nima negativnih vplivov na dobro počutje živali, nastanjenih v ustanovi.
Requirements for installations and equipment
Zahteve za naprave in opremo
Member States shall ensure that all establishments of a breeder, supplier or user have installations and equipment suited to the species of animals housed and, where procedures are carried out, to the performance of the procedures.
Države članice zagotovijo, da imajo vse ustanove rejca, dobavitelja ali uporabnika naprave in opremo, ki so primerni za nastanjene živalske vrste, ter v ustanovah, v katerih se izvajajo postopki, ustrezne tudi za izvajanje postopkov.
The design, construction and method of functioning of the installations and equipment referred to in paragraph 1 shall ensure that the procedures are carried out as effectively as possible, and aim at obtaining reliable results using the minimum number of animals and causing the minimum degree of pain, suffering, distress or lasting harm.
Oblika, zgradba in metode delovanja naprav in opreme iz odstavka 1 morajo zagotavljati čim učinkovitejše izvajanje postopkov s ciljem pridobiti zanesljive rezultate ob uporabi najmanjšega števila živali in povzročanjem najnižje stopnje bolečin, trpljenja, stiske ali trajnih poškodb.
For the purposes of implementation of paragraphs 1 and 2, Member States shall ensure that the relevant requirements as set out in Annex III are complied with.
Države članice za namene izvajanja odstavkov 1 in 2 zagotovijo, da so izpolnjene ustrezne zahteve iz Priloge III.
Competence of personnel
Usposobljenost osebja
Member States shall ensure that each breeder, supplier and user has sufficient staff on site.
Države članice zagotovijo, da ima vsak rejec, dobavitelj in uporabnik na voljo zadosti osebja na kraju samem.
The staff shall be adequately educated and trained before they perform any of the following functions:
Osebje mora imeti ustrezno izobrazbo in biti ustrezno usposobljeno pred opravljanjem katere koli izmed naslednjih funkcij:
carrying out procedures on animals;
izvajanje postopkov na živalih;
designing procedures and projects;
zasnova postopkov in projektov;
taking care of animals; or
oskrba živali ali
killing animals.
usmrtitev živali.
Persons carrying out the functions referred to in point (b) shall have received instruction in a scientific discipline relevant to the work being undertaken and shall have species-specific knowledge.
Osebe, ki izvajajo funkcije iz točke (b), morajo imeti ustrezno izobrazbo iz znanstvenega področja, povezanega z delom, ki ga izvajajo, in morajo imeti specifično znanje na področju zadevne živalske vrste.
Staff carrying out functions referred to in points (a), (c) or (d) shall be supervised in the performance of their tasks until they have demonstrated the requisite competence.
Osebje, ki izvaja funkcije iz točk (a), (c) ali (d), svoje naloge opravlja pod nadzorom, dokler ne izkaže zahtevane strokovne usposobljenosti.
Member States shall ensure, through authorisation or by other means, that the requirements laid down in this paragraph are fulfilled.
Države članice z izdajo dovoljenj ali drugih sredstev zagotovijo, da so zahteve iz tega odstavka izpolnjene.
Member States shall publish, on the basis of the elements set out in Annex V, minimum requirements with regard to education and training and the requirements for obtaining, maintaining and demonstrating requisite competence for the functions set out in paragraph 2.
Države članice na podlagi elementov iz Priloge V objavijo najmanjše zahteve v zvezi z izobrazbo, usposobljenostjo in zahtevami za pridobitev, ohranjanje in dokazovanje potrebne strokovne usposobljenosti za funkcije iz odstavka 2.