natgillin/translations-raw huggingface dataset:
nadomestitvi in zmanjšanju uporabe živali v postopkih ter izboljšanju vzreje, namestitve, oskrbe in uporabe živali v postopkih;
the replacement and reduction of the use of animals in procedures and the refinement of the breeding, accommodation, care and use of animals in procedures;
izvoru, vzreji, označevanju, oskrbi in namestitvi živali;
the origin, breeding, marking, care and accommodation of animals;
delovanju vzrejnih, dobavnih ali uporabniških enot;
the functioning of breeding, supplying or user establishments;
vrednotenju in odobritvi projektov, v katerih postopkih se uporabljajo živali.
the evaluation and authorisation of projects involving the use of animals in procedures.
Ta direktiva se uporablja
This Directive shall apply
uporabljajo v postopkih ali so namenjene uporabi v postopkih ali kadar se živali redijo predvsem z namenom, da bodo njihovi organi ali tkiva uporabljeni za znanstvene namene
animals ▌ used or intended to be used in procedures║ or where they are bred specifically so that their organs or tissues may be used for scientific purposes,
, ter ureja vse uporabe živali v postopkih, ki jim lahko povzročijo bolečino, trpljenje, stisko ali trajne poškodbe
and shall cover all uses of animals in procedures that are likely to cause them pain, suffering, distress or lasting harm
njihova odprava
Where there is any
z uspešno uporabo anestezije, analgetikov ali drugih metod
pain, suffering, distress or lasting harm,
ne izključuje
its elimination
uporabe živali v poskusih ║ s področja uporabe te direktive.
by the successful use of anaesthesia, analgesia or other methods shall not exclude the use of an animal in procedures from the scope of this Directive.
od zadnje tretjine njihovega običajnega razvoja;
as from the last third of their normal development;
v Prilogi I.
listed in Annex I.
Razen za splošne preglede objektov za rejo se
Other than the general checks on breeding facilities
neeksperimentalne, kmetijske ali klinične veterinarske prakse in poskuse;
non-experimental, agricultural or clinical veterinary practices and trials;
prakse, ki se izvajajo za namene priznane vzreje živali;
practices undertaken for the purposes of recognised animal husbandry;
prakse, ki se izvajajo predvsem za namene označevanja živali;
practices undertaken for the primary purpose of marking an animal;
Ta direktiva se uporablja brez poseganja v Direktivo Sveta 76/768/EGS
This Directive shall apply without prejudice to Council Directive 76/768/EEC
z dne 27. julija 1976
of 27 July 1976
o približevanju zakonodaje držav članic v zvezi s kozmetičnimi izdelki
on the approximation of the laws of the Member States relating to cosmetic products
V tej direktivi se uporabljajo naslednje opredelitve:
For the purposes of this Directive the following definitions shall apply:
ali pa ne
or may not
povzroči bolečino, trpljenje, stisko ali trajne poškodbe,
cause the animal pain, suffering distress or lasting harm
ter zajema vsako ukrepanje
and includes
, ki povzroči ali lahko povzroči rojstvo živali v takih okoliščinah ali nastanek nove genetsko spremenjene linije živali;
any course of action intended, or liable, to result in the birth of an animal in any such condition or in the creation of a new genetically modified animal line;
"pristojni organ" pomeni organ ali organe, ki jih določi vsaka država članica kot pristojne za nadzorovanje izvajanja direktive;
"competent authority' means the authority or authorities designated by each Member State as being responsible for supervising the enforcement of this Directive;
"etični pristop" je pristop, ki se uporabi pred poskusi ter zajema oceno znanstvene in družbene utemeljenosti uporabe živali ob upoštevanju dejstva, da mora človek spoštovati živali kot živa in čuteča bitja;
"ethical approach' means the approach which precedes experimentation and consists of assessing the scientific and societal grounds for using animals, with reference to humankind's duty to respect animals as living, sentient beings;
"pristojna oseba" pomeni vsako osebo, ki v državi članici velja kot pristojna za opravljanje ustrezne funkcije, ki je opisana v tej direktivi;
"competent person' means any person who is considered by a Member State to be competent to perform the relevant function described in this Directive;
"vzreja" pomeni vse tiste dejavnosti, ki so potrebne za rejo in ohranjanje fenotipsko normalnih živali za znanstvene ali druge namene, vendar same niso del poskusov;
"husbandry' means all those activities required to breed and maintain phenotypically normal animals, whether for scientific or other purposes, but which do not themselves constitute experiments;
"praksa" pomeni vsako neeksperimentalno ali vsako znanstveno dejavnost, ki ni del poskusa;
"practice' means any non-experimental activity or any scientific activity which does not constitute an experiment;
"primerno anesteziran" pomeni omrtvičen s tako učinkovitimi anestezijskimi metodami, lokalnimi ali splošnimi, kot se uporabljajo v dobri veterinarski praksi;
"properly anaesthetised' means deprived of sensation by means of anaesthesia, whether local or general, which is as effective as those used in good veterinary practice;
"protokol" pomeni vrsto postopkov, ki so del poskusa z določenim ciljem;
"protocol' means a series of procedures that constitute an experiment with a defined objective;
"regulativni postopek" pomeni vsak poskusni ali drug znanstveni postopek, ki bo verjetno imel za posledico bolečino, trpljenje, stisko ali trajno poškodbo zaščitene živali;
"regulated procedure' means any experimental or other scientific procedure, which is likely to have the effect of causing a protected animal pain, suffering, distress or lasting harm;
"vnovična uporaba" pomeni uporabo živali, ki je že bila uporabljena v postopku, kadar je mogoče uporabiti drugo žival, na kateri prej ni bil izveden noben postopek;
"re-use' means the use of an animal already used in a procedure, when a different animal on which no procedure has previously been carried out could also be used;
"zaupne informacije" pomenijo informacije, katerih nesporazumna objava bi posegala v legitimne gospodarske ali druge interese njihovega lastnika ali tretje strani;
"confidential information' means information, the non-consensual release of which could prejudice the legitimate commercial or other interests of its owner or a third party.
Nadomestitev, zmanjšanje in izboljšanje
Replacement, reduction and refinement
obstajajo preskusne metode, poskusi ali druge znanstvene dejavnosti
experimentation or other scientific activity
ob predpostavki, da v zadevni državi članici ni prepovedana.
, provided it is not prohibited in the Member State concerned.
V okviru te direktive se preskusne metode, ki vključujejo uporabo celic človeškega zarodka in plodu, ne štejejo za alternativne, kar pomeni, da lahko države članice v zvezi z uporabo teh preskusnih metod sprejemajo lastne etične odločitve.
Pursuant to this Directive, testing methods which involve the use of human embryonic and foetal cells shall not be regarded as alternatives, in other words the Member States may take their own ethical decisions concerning the use of these methods of testing.
Države članice zagotovijo, da se število živali, ki se uporabljajo v projektih, zmanjša na minimum, ne da bi pri tem bili ogroženi cilji projekta.
Member States shall ensure that the number of animals used in projects is reduced to the minimum without compromising the objectives of the project.
Države članice zagotovijo izboljšanje vzreje, namestitve in oskrbe ter izboljšanje metod, ki se uporabljajo v postopkih, tako da se morebitne bolečine, trpljenje, stiska ali trajne poškodbe, povzročene živalim, odpravijo ali zmanjšajo na minimum.
Member States shall ensure refinement of breeding, accommodation and care, and of methods used in procedures, eliminating or reducing to the minimum any possible pain, suffering, distress or lasting harm to the animals.
Države članice zagotovijo sredstva za usposabljanje, raziskave in razvoj znanstveno zadovoljivih metod ali preskusnih strategij brez uporabe živali ter njihovo izvajanje.
Member States shall ensure that funding is provided for training and research on, and development and implementation of, scientifically satisfactory methods or testing strategies that do not entail the use of animals.
Države članice zagotovijo, da se ustreznim osebam in ustanovam zagotovi usposabljanje o uporabi znanstveno zadovoljivih metod ali preskusnih strategij brez uporabe živali, ter spodbujajo te metode oz. preskusne strategije.
Member States shall ensure that training is provided on the use of scientifically satisfactory methods or testing strategies that do not entail the use of animals, to appropriate persons and establishments, and promote such methods or testing strategies.
Nameni postopkov
Purposes of procedures
Postopki se lahko izvajajo samo za naslednje namene:
Procedures may be carried out for the following purposes only:
temeljne raziskave za razvijanje znanja v bioloških ali vedenjskih vedah;
basic research for the advancement of knowledge in biological or behavioural sciences;
izogibanje, preprečevanje, odkrivanje ali zdravljenje bolezni, bolehnosti, drugih nenormalnosti ali njihovih učinkov pri ljudeh, živalih ali rastlinah;
the avoidance, prevention, diagnosis or treatment of disease, ill-health or other abnormality or their effects in human beings, animals or plants;
ocena, odkrivanje, uravnavanje ali spreminjanje fizioloških razmer pri človeku, živalih ali rastlinah;
the assessment, detection, regulation or modification of physiological conditions in human beings, animals or plants;
izboljšanje proizvodnih pogojev in dobrega počutja živali iz vzreje za kmetijske namene.
the improvement of the production conditions and welfare of animals reared for agricultural purposes;
varstvo naravnega okolja, ki je v interesu zdravja ali dobrega počutja človeka ali živali;
the protection of the natural environment in the interests of the health or welfare of human beings or animals;
varstvo zdravja ljudi, ko gre za izpostavljenost kemikalijam delavcev ali potrošnikov;
the protection of human health in the context of workers' or consumers' exposure to chemicals;
raziskave, usmerjene v ohranitev
research aimed at preservation,
, zdravje in dobro počutje
health and welfare
višje izobraževanje ali usposabljanje;
higher education or training;
sodnomedicinske preiskave.
forensic inquiries.
Humane metode ubijanja
Humane methods of killing
Kjer je možna in že razpoložljiva bolj humana metoda ubijanja, se lahko uporabi, tudi če ni vključena v Prilogo VI
Where a more humane method of killing is possible and readily available, it may be used even if it is not included in Annex VI
Pristojni organi lahko odobrijo izjeme od odstavka 1 na podlagi znanstvene utemeljitve, da namena postopka ni mogoče doseči s humano metodo ubijanja
Competent authorities may grant exemptions from paragraph 1 on the basis of scientific justification that the purpose of the procedure cannot be achieved by the use of a humane method of killing
, ali če dokažejo, da so bile razvite metode, ki bolj spoštujejo varstvo živali
or that other methods providing better animal protection have been developed
Živali se brez izjeme ubijejo tako, da čutijo najmanj bolečine, trpljenja in stiske.
Notwithstanding any exemption, animals shall be killed with a minimum of pain, suffering and distress.
Odstavek 1 se ne uporablja v primerih, v katerih je žival treba ubiti v nujnih okoliščinah zaradi dobrobiti živali.
Paragraph 1 shall not apply where an animal has to be killed in emergency circumstances for animal welfare reasons.
Nujne okoliščine iz prvega pododstavka določijo države članice.
Member States shall determine the emergency circumstances referred to in the first subparagraph.
DOLOČBE O UPORABI NEKATERIH ŽIVALI V POSTOPKIH
PROVISIONS ON THE USE OF CERTAIN ANIMALS IN PROCEDURES
Ogrožene vrst, ki niso primati razen človeka
Endangered species other than non-human primates
Ogrožene vrste, ki so naštete v Prilogi A k Uredbi Sveta (ES) št. 338/97 UL L 61, 3.3.1997, str.
Endangered species listed in Annex A to Council Regulation (EC) No 338/97 OJ L 61, 3.3.1997, p.
, se v postopkih ne uporabljajo, razen v tistih postopkih, ki izpolnjujejo naslednje pogoje:
shall not be used in procedures, with the exception of those procedures meeting the following conditions:
postopek ima enega od namenov, ki so navedeni v točki (2)(a) ali točkah (3) ali
the procedure has one of the purposes referred to in points (2)(a), (3) or
člena 5;
of Article 5;
Ta člen se ne uporablja za nobeno vrsto primatov razen človeka.
This article shall not apply to any species of non-human primates.
Primati razen človeka
Non-human primates
, razen v tistih, ki izpolnjujejo naslednje pogoje:
non-human primates shall not be used in procedures, with the exception of those procedures meeting the following conditions:
utemeljitev, da namena postopka ni mogoče doseči z uporabo vrste, ki ni vrsta primatov razen človeka.
justification that the purpose of the procedure cannot be achieved by the use of other species than non-human primates.
Ne glede na določbe odstavka 1 se velike opice ne uporabljajo v postopkih s pridržkom uporabe zaščitna klavzula iz
Notwithstanding paragraph 1, great apes shall not be used in procedures, subject to the use of the safeguard clause in
Komisija vsaki dve leti, prvič
Every two years, and for the first time
, po posvetovanju z državami članicami opravi pregled uporabe primatov razen človeka v postopkih in objavi njene ugotovitve.
, the Commission shall, in consultation with Member States, conduct a review of the use of non-human primates in procedures and publish the results thereof.
Živali, vzrejene za uporabo v postopkih
Animals bred for use in procedures
Kjer je izvedljivost ugotovljena,
Where feasibility is established
bodo od datumov, določenih v Prilogi III,
, as from the dates to be set in Annex III
v skladu z oceno iz pododstavka 1
in light of the evaluation referred to in subparagraph 1
države članice zagotovile, da se primati razen človeka, navedeni v tej prilogi, lahko uporabljajo v postopkih, samo kadar
, Member States shall ensure that non-human primates listed in that Annex may only be used in procedures where they are
izvirajo iz samooskrbnih kolonij
sourced from self-sustaining colonies
Pristojni organi lahko odobrijo izjeme od
Competent authorities may grant exemptions from
pododstavkov 2 in 3
subparagraphs 2 and 3 of paragraph 1
odstavka 1
on the basis of a
na podlagi veterinarske utemeljitve iz razlogov dobrega počutja živali ali
veterinary justification for reasons of animal welfare or on the basis of a
na podlagi znanstvene utemeljitve.
scientific justification.
Potepuške in podivjane domače živali
Stray and feral animals of domestic species
Potepuške in podivjane domače živali se ne uporabljajo v postopkih.
Stray and feral animals of domestic species shall not be used in procedures.
Uporaba trupel, tkiv in organov živali za usposabljanje
Use of cadavers, tissue and organs of animals for training purposes
Države članice zagotovijo, da se postopki vedno izvajajo v ▌ enotah
Member States shall ensure that procedures are always carried out in ▌establishments
, opredeljenih v členu 3
as defined in Article 3
Pristojni organ lahko odobri izjemo od prvega pododstavka na podlagi znanstvene utemeljitve.
The competent authority may grant an exemption from the first subparagraph on the basis of scientific justification.
Postopki se lahko izvajajo samo znotraj projekta.
Procedures may be carried out only within the framework of a project.
Metode, uporabljene v postopkih
Methods used in procedures
Smrti kot končnemu rezultatu v postopku se je treba izogniti, kolikor je le mogoče, in jo zamenjati z zgodnjimi in humanimi končnimi rezultati.
Death as the end-point in a procedure shall be avoided as far as possible and replaced by early and humane end-points.
Če se smrti kot končnemu rezultatu ni mogoče izogniti, se postopek načrtuje tako, da umre najmanjše mogoče število živali.
If death as the end-point is unavoidable, the procedure shall be designed so as to result in the deaths of as few animals as possible.
vsi postopki izvajajo pod splošno ali lokalno anestezijo
all procedures are carried out under general or local anaesthesia
ali z drugimi metodami, ki lahko blažijo bolečino ali zmanjšajo trpljenje
or using other methods that may alleviate pain or minimise suffering
kadar se presodi, da je anestezija za žival bolj škodljiva kot sam postopek;
) where anaesthesia is judged to be more traumatic to the animal than the procedure itself;
kadar je anestezija nezdružljiva z namenom postopka, razen če postopek vključuje resne poškodbe, ki lahko povzročijo hude bolečine.
) where anaesthesia is incompatible with the purpose of the procedure unless the procedure involves serious injuries that may cause severe pain.
Če se postopek izvaja brez anestezije, se uporabijo analgetiki ali druge primerne metode,
If the procedure is carried out without anaesthesia, analgesics or other appropriate methods shall be used
kadar koli bi to koristilo živalim,
wherever this would be beneficial to the animal
s katerimi se zagotovi, da bodo bolečine, trpljenje in stiska, ki se jim ni mogoče izogniti, omejeni na minimum.
to ensure that unavoidable pain, suffering and distress are kept to a minimum.
V teh primerih se poda znanstvena utemeljitev, ki jo spremljajo podrobnosti o sistemu dajanja anestetika ali analgetika.
cases, a scientific justification shall be provided, accompanied by the details of the anaesthetic or analgesic regime.
Žival, ki lahko trpi ▌ bolečine, ko anestezija preneha delovati, se pravočasno zdravi s preventivnimi in pooperacijskimi analgetiki ali drugimi primernimi metodami za lajšanje bolečin, če je to skladno z namenom postopka.
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.
Razvrstitev glede na težo posledic postopkov
Classification of severity of procedures
znanstveno utemeljeni, nadzoruje pa se tudi njihova etičnost
scientifically justified, and ethically monitored
, če ▌ bolečina, trpljenje ali stiska
if the pain, suffering or distress is likely to be
ne bodo zgolj prehodni
more than transient
merila za stopenjsko razvrstitev postopkov
the criteria for classification of procedures
, kot so določena v Prilogi IX, na podlagi mednarodnih stopenjskih razvrstitev in v skladu z najboljšimi praksami, razvitimi v Evropski uniji
as referred to in Annex IX on the basis of international classifications and in line with best practices developed within the European Union
Takšna merila naj obsegajo zgornjo mejo teže posledic, ki je pri postopkih na živalih ne bo dovoljeno prekoračiti.
Such criteria shall include an upper limit of severity beyond which procedures on animals will be prohibited.
18 mesecev od začetka veljavnosti te direktive.
18 months after the entry into force of this Directive.
Države članice zagotovijo, da se žival,
Member States shall ensure that an animal
na kateri je
on which a procedure has
bil izveden postopek
been carried out
, kadar je mogoče uporabiti drugo žival, na kateri prej ni bil izveden noben
, when a different animal on which no
pripravljalni ali kateri drugi
preparatory or other
samo takrat, ko so izpolnjeni vsi naslednji pogoji:
only when all of the following conditions are met:
predhodni postopek je bil razvrščen kot ║do vključno
the previous procedure was classified as up to '
dokazano je bilo, da je njeno splošno zdravstveno stanje in dobro počutje v celoti povrnjeno;
it is demonstrated that its general state of health and well-being has been fully restored;
nadaljnji postopek je razvrščen kot ║do vključno
the further procedure is classified as up to '
Z odstopanjem od odstavka 1 lahko pristojni organ na podlagi znanstvene utemeljitve dovoli vnovično uporabo živali,
By way of derogation from paragraph 1, the competent authority, on the basis of scientific justification, may allow re-use of an animal
če je postopek, ki je bil predhodno izveden na tej živali, razvrščen kot do vključno "zmeren"
where the previous procedure performed on the animal is classified as up to 'moderate"
ter je nadaljnji postopek razvrščen kot ║do vključno
and the further procedure is classified as up to '
Konec postopka
End of the procedure
Za postopek se šteje, da se je končal, kadar nadaljnjih opažanj za ta postopek ne bo več, ali v povezavi z novimi linijami genetsko spremenjenih živali, kadar je mogoče znanstveno dokazati neobstoj škodljivih učinkov za živali.
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 lack of adverse effects to animals can be scientifically demonstrated.
Na koncu postopka veterinar ali druga pristojna oseba sprejme odločitev o tem, ali se bo žival ohranila pri življenju ali bo ubita s humano metodo.
At the end of a procedure, a decision shall be taken by a veterinarian or by another competent person on whether the animal shall be kept alive or killed by a humane method.
Po koncu postopka se žival
At the end of a procedure
ubije s humano metodo, kadar obstaja verjetnost, da bo trpela trajne bolečine ali stisko.
an animal shall be killed by a humane method when it is likely to remain in lasting pain or distress.
Kadar se žival ohrani pri življenju, prejme oskrbo in namestitev, ki sta ustrezni za njeno zdravstveno stanje, in je pod nadzorom veterinarja ali druge pristojne osebe.
Where an animal is to be kept alive, it shall receive the care and accommodation appropriate to its state of health and be placed under the supervision of a veterinarian or another competent person.
spodbujajo uvedbo programov
encourage the establishment of
za izmenjavo organov in tkiv živali, ki so bile ubite s humano metodo.
programmes for the sharing of organs and tissues of animals killed by a humane method.
Spuščanje živali na prostost in vnovična nastanitev v domovih
Setting free of animals and re-homing
Države članice lahko dovolijo, da se živali, ki se uporabljajo v postopkih ali so namenjene uporabi v postopkih,
Member States may allow animals used or intended to be used in procedures to be
spustijo v njihov izvorni habitat, vrnejo v vzrejni sistem, primeren za zadevno vrsto,
released into their original habitat, returned to a husbandry system appropriate to the species,
ali znova nastanijo v domovih, če so izpolnjeni naslednji pogoji:
or re–homed provided that the following conditions are met:
zdravstveno stanje živali to omogoča;
the state of health of the animal allows it;
ni nevarnosti za javno zdravje ali okolje;
there is no danger to public health or the environment;
kolikor je bilo mogoče, je bilo poskrbljeno za zaščito dobrega počutja živali
the maximum possible care has been taken to safeguard the well-being of the animal
zadevne živali niso genetsko spremenjene poskusne živali ali primati razen človeka.
the animals concerned are not genetically modified experimental animals or non-human primates.
Odobritev oseb
Authorisation of persons
Države članice zagotovijo, da pristojni
Member States shall ensure that persons are authorised by the competent authority
ali pooblaščeni
or the delegated authority
organ odobri osebe, preden začnejo izvajati katero koli od naslednjih nalog:
before they carry out any of the following functions:
izvajanje postopkov na živalih, vključno z ubijanjem živali s humano metodo;
the carrying out of procedures on animals, including their killing by a humane method;
nadzorovanje ali načrtovanje postopkov in projektov;
the supervision or design of procedures and projects;
nadzorovanje oseb, ki skrbijo za živali.
the supervision of those taking care of animals.
Države članice zagotovijo, da imajo osebe iz odstavka 1 za namene odobritve primerno
Member States shall ensure that, for the purposes of the authorisation, the persons referred to in paragraph 1 have the appropriate
veterinarsko ali znanstveno
veterinary or scientific
izobrazbo in usposobljenost in
education and training and have