natgillin/translations-raw huggingface dataset:
(d) ustreznim organom in uporabniškim enotam v državah članicah in med njimi zagotavljajo znanstveno in tehnično pomoč pri sprejemanju in izvajanju alternativnih metod;
(d) provide scientific and technical assistance to the relevant authorities and to user establishments , within and between the Member States , for the acceptance and implementation of alternative methods;
Člen 46 – odstavek 4 – točka (e)
Article 46 – paragraph 4 – point e
(e) osebam iz člena 20(1) zagotavljajo usposabljanje o uporabi alternativnih metod.
(e) provide training on the use of alternative methods to persons referred to in Article 20(1).
(e) osebam iz člena 20(1) in, če se zahteva, uporabniškim enotam zagotavljajo usposabljanje o uporabi alternativnih metod.
(e) provide training on the use of alternative methods to persons referred to in Article 20(1) and , if required, to user establishment s .
Člen 46 – odstavek 4 – točka e a (novo)
Article 46 – paragraph 4 – point e a (new)
(ea) sporočajo o razvoju alternativnih metod in javnost obveščajo o pozitivnih in negativnih rezultatih.
ea) communicate developments on alternative methods and inform the public of positive and negative outcomes .
Države članice letno zberejo in javno objavijo statistične podatke o uporabi živali v postopkih, vključno s podatki o dejanski teži postopkov ter izvoru in vrstah primatov razen človeka, ki se uporabljajo v postopkih.
Member States shall collect and make publicly available , on an annual basis, statistical information on the use of animals in procedures, including information on the actual severity of the procedures and on the origin and species of non-human primates used in procedures.
Države članice letno zberejo statistične podatke o uporabi živali v postopkih, vključno s podatki o dejanski teži postopkov ter izvoru in vrstah primatov razen človeka, ki se uporabljajo v postopkih.
Member States shall collect, on an annual basis, statistical information on the use of animals in procedures, including information on the actual severity of the procedures and on the origin and species of non-human primates used in procedures.
Člen 49 – odstavek 2 – pododstavek 2
Article 49 – paragraph 2 – subparagraph 2
Države članice predložijo Komisiji te statistične podatke do [tri leta po dnevu prenosa v zakonodajo] in nato vsako leto po tem .
Member States shall submit that statistical information to the Commission by [three years from transposition date] and every year thereafter.
Države članice te statistične podatke objavijo in jih predložijo Komisiji do [tri leta po dnevu prenosa v zakonodajo] in nato v presledkih, ki niso daljši od dveh let .
Member States shall make that statistical information publicly available and submit it to the Commission by [three years from transposition date] and thereafter at intervals not exceeding two years .
Komisija pregleda to direktivo do [ 10 let po datumu začetka veljavnosti], pri tem pa upošteva napredek pri razvoju alternativnih metod, ki ne vključujejo uporabe živali in zlasti primatov razen človeka, ter predlaga morebitne spremembe, kadar je to primerno.
The Commission shall review this Directive by [ 10 years after the date of entry into force] taking into account advancement in development of alternative methods not entailing the use of animals, and in particular of non-human primates, and propose any amendments, where appropriate.
Komisija pregleda to direktivo do [ pet let po datumu začetka veljavnosti], pri tem pa upošteva napredek pri razvoju alternativnih metod, ki ne vključujejo uporabe živali in zlasti primatov razen človeka, ter predlaga morebitne spremembe, kadar je to primerno.
The Commission shall review this Directive by [ 5 years after the date of entry into force] taking into account advancement in development of alternative methods not entailing the use of animals, and in particular of non-human primates, and propose any amendments, where appropriate.
Glede na hitrost znanstvenega razvoja in vse večje razumevanje dovzetnosti živali za trpljenje je treba direktivo pregledati prej.
Considering the pace of scientific development and increasing understanding of the ability of animals to suffer mean that the directive should be reviewed sooner.
Člen 53 a (novo)
Article 53 a (new)
Tematski pregled
Thematic review
Komisija v posvetovanju z državami članicami in ustreznimi zainteresiranimi stranmi opravi tematski pregled uporabe živali v postopkih vsaki dve leti, začenši dve leti po začetku veljavnosti te direktive.
The Commission shall, in consultation with Member States and any relevant stakeholders, conduct a thematic review of the use of animals in procedures every two years commencing two years after the entry into force of this Directive.
V pregledu preuči vpliv napredka v znanju na področju tehnologije, znanosti in dobrega počutja živali ter določi cilje za izvajanje potrjenih nadomestnih metod.
The review shall examine the impact of developments in technological, scientific and animal welfare knowledge, and set targets for the implementation of validated replacement methods.
Pregled po desetih letih od začetka veljavnosti te direktive ne bi mogel biti v koraku s tehnološkim in znanstvenim napredkom.
A review which takes place ten years after entry into force of the Directive would be unable to keep pace with the technological and scientific progress.
Zato se predlaga vrsta rednih tematskih pregledov, ki bodo omogočili bolj usmerjen pristop k uporabi živali na specifičnih področjih raziskav in preskusov.
Consequently a series of thematic, regular reviews is proposed to allow a more focussed approach to the use of animals in specific areas of research and testing.
Priloga I – naslov
Annex I - Title
Vrste nevretenčarjev iz člena 2(2)
Invertebrate Species referred to in Article 2 (2)
Redovi nevretenčarjev iz člena 2(2)
Invertebrate Orders referred to in Article 2 (2)
Priloga I – točka 1
Annex I – line 1
Vključitev obloustk bi imela velik birokratski učinek in učinek na število poskusnih živali, o katerih se poroča, hkrati pa to ne bi prispevalo k dobremu počutju živali.
Including cyclostomes will have a huge bureaucratic impact and impact on reported numbers of experimental animals, with no benefit for animal welfare.
Priloga I
Annexe I
deseteronožci nižjih redov rakovic in košarjev
Decapod crustaceans of the infraorders Brachyura and Astacidea
Če naj se nevretenčarji vključijo v področje uporabe direktive, je treba prilogo I posodobiti, da bo bolj usklajena z znanstvenim mnenjem.
If invertebrates are indeed to be included within the scope of the Directive, Annex I needs to be updated in order to better reflect scientific opinion.
Poročilo Sveta za zdravstveno varstvo in dobro počutje živali pri Evropski agenciji za varnost hrane navaja le velike deseteronožce, ki hodijo, kot so rakovice in jastogi; ti kažejo „kompleksno vedenje“, „določeno stopnjo zavedanja“, „bolečinski sistem“ in „precejšnjo sposobnost učenja“.
The report of the EFSA scientific panel on Animal Health and Welfare only refers to the large or “walking” decapods such as crabs and lobsters as exhibiting “complex behaviour”, “some degree of awareness”, “a pain system” and “considerable learning ability”.
Zato se predlaga jasna razlika med velikimi deseteronožci, ki hodijo, kot so rakovice (nižji red rakovice) in jastogi (nižji red košarji), ter drugimi deseteronožci.
A clear distinction between the large or "walking" decapods such as crabs (infraorder Brachyura) and lobsters (infraorder Astacidea) and other decapods is therefore proposed.
kunec (Oryctolagus cuniculus);
Rabbit (Oryctolagus cuniculus)
V številnih južnoevropskih državah je kunec žival za vzrejo (domača vrsta, ki jo gojijo kmetje in katere proizvodi so namenjeni prehrani ljudi).
The rabbit is considered to be a production animal (domestic species bred by farmers, the products of which are intended for human consumption) in a number of southern European countries.
Nujno je zagotoviti možnost opravljanja poskusov na teh živalih, rejenih v kmetijske in ne v poskusne namene, saj bi bilo diskriminatorno zahtevati, da se živali iste vrste vzrejajo na ločenih krajih, glede na to, ali so namenjene za raziskave ali za vzrejo.
It is essential to ensure the possibility of testing on such animals bred for agricultural purposes and not testing purposes as it would be discriminatory to require that the same species be bred on separate farms, depending on whether it is intended for research purposes or for production purposes.
Priloga II – točka 11 a (novo)
Annex II – point 11 a (new)
11a. cebrica (Danio danio)
Zebrafish (danio danio)
Cebrica (Danio danio) je laboratorijska vrsta z mnogimi genetskimi različicami, ki se zelo razlikujejo od prvotne prostoživeče vrste.
The zebrafish (danio danio) is a laboratory species with very many genetic variants which now differs significantly from the original wild species.
Priloga III – točka 3 - stolpec 2
Annex III – line 3 - column 2
[ 7 let po prenosu Direktive]
7 years after transposition of Directive
[ deset let po prenosu Direktive]
1 0 years after transposition of Directive
Glede na to, da sedaj še ni vzpostavljena izvedljivost in stalnost dobave, se predlaga podaljšanje roka za spremembo na deset let za vse vrste (razen marmozetk) ter vključitev vmesne ocene izvedljivosti.
Given that the feasibility and continuity of supply are not yet established at this point, it is proposed to extend the timelines for switch to 10 years for all species (except marmosets) and to include a mid-term feasibility review.
Priloga III – točka 4 - stolpec 2
Annex III – line 4 - column 2
Priloga IV – podnaslov (novo)
Annex IV – subtitle (new)
Oskrba in pogoji za namestitev morajo biti prilagojeni znanstvenemu cilju.
The care and accommodation conditions should be tailored to the scientific objective.
Pogoji za namestitev živali za poskuse morajo biti skladni z znanstvenimi cilji projekta, zaradi katerih so včasih potrebni posebni pogoji za poskuse.
The accommodation conditions for the test animal should be in line with the scientific objectives of the project, which sometimes require specific test conditions.
Za nekatere poskuse na živalskih vrstah, pomembnih za kmetijstvo, je nujno, da se žival vzdržuje v pogojih običajne vzreje.
For example, for certain tests on species of agronomic interest it is essential that the animal is kept in normal breeding conditions.
Priloga IV – točka 1 – uvodni del
Annex IV – point 1 – introductory part
FIZIČNI OBJEKTI
THE PHYSICAL FACILITIES
Pogoji za namestitev so prilagojeni znanstvenemu cilju.
The accommodation conditions shall be tailored to the scientific objective.
Priloga IV – točka 3 – uvodni del
Annex IV – point 3 – introductory part
Oskrba je prilagojena znanstvenemu cilju.
The care shall be tailored to the scientific objective.
Priloga V – tabela 5 – stolpec „Skupna ocena“ – Ogljikov dioksid
Annex V – table 5 – ‘Overall rating’ column – Carbon dioxide
1 – če je edini agent.
1 - if sole agent
5 – če je žival nezavestna
5 - if animal unconscious
Ta metoda pri glodavcih ne povzroča trpljenja, če se ogljikov dioksid dodaja postopno.
This method causes no suffering for rodents, provided that the carbon dioxide is introduced gradually.
Zato se zdi pretirano razvrstiti metodo med nezadovoljive, kadar je ogljikov dioksid edini agent, saj so številni laboratoriji primerno opremljeni zanjo in obvladajo njeno izvajanje, ki ga ocenjujejo kot zadovoljivo.
It seems therefore excessive to classify it as unsatisfactory when used alone, given too that many laboratories are now equipped for, and have mastered, this practice, which they judge to be satisfactory.
Priloga VIIa (novo)
Annex VIIa (new)
PRILOGA VIIa
ANNEX VIIa
Splošne opredelitve stopenj glede na težo posledic iz člena 15(1)
General Definitions of Degrees of Severity referred to in Article 15(1)
Predpostavlja se, da postopki, ki povzročajo bolečine ljudem, povzročajo bolečine tudi živalim, razen če je znano ali ugotovljeno drugače.
Unless the contrary is known or established it should be assumed that procedures that cause pain in humans also cause pain in animals.
Brez bolečin ali blaga bolečina: stopnja teže posledic 1
No pain or mild pain : Severity Grade 1
Posegi na živalih in ravnanje z njimi za namene poskusa, zaradi katerih živali ne izkusijo bolečine ali za kratek čas izkusijo blago bolečino, trpljenje, poškodbo ali blago stisko, njihovo splošno stanje pa se bistveno ne poslabša.
Interventions and manipulations in animals for experimental purposes as a result of which the animals experience no pain or short term mild pain, suffering, injury, or mild distress with no significant impairment of their general condition.
– študije z različno sestavo krme ali nefiziološko prehrano z blagimi kliničnimi znaki ali simptomi;
- studies with differing feed compositions or with unphysiological diet, with minor clinical signs or symptoms.
–odvzem vzorcev krvi ali injekcija zdravila (s.c., i.m., i.p. i.v.);
- withdrawal of blood samples or injection (s.c., i.m., i.p., i.v.) of a drug.
– biopsija površinskega tkiva v anesteziji;
- superficial tissue biopsy under anaesthesia
– nevsiljive tehnike slikanja, z uporabo pomirjeval ali anestezije pri živalih ali brez njih;
- non-invasive scanning techniques, with or without sedation or anaesthesia of the animals
– študije tolerance, ki pričakovano povzročijo kratkotrajne, blage, lokalne ali sistemske reakcije;
- tolerability studies which give cause to expect short term, minor, local or systemic reactions
– snemanje elektrokardiograma (EKG) pri živalih pri zavesti;
- Electrocardiogram ( ECG ) recordings in conscious animals
– opazovalne študije, kot so test odprtega polja, testi z labirinti ali test stopnic;
- observational studies such as open-field test, labyrinth tests, or staircase test
– poskusi v splošni anesteziji brez okrevanja.
- experiments under general anaesthesia without recovery
Zmerna: stopnja teže posledic 2
Moderate: Severity Grade 2
Posegi na živalih in ravnanje z njimi za namene poskusa, pri katerih živali za kratek čas izkusijo zmerno stisko ali srednje dolgo ali dolgo izkusijo blago stisko, bolečino, trpljenje ali poškodbo ali bistveno poslabšanje splošnega stanja.
Interventions and manipulations in animals for experimental purposes which subject the animals to short term moderate distress, or a moderately long to long-lasting episode of mild distress, pain, suffering, or injury, or significant impairment of general condition.
– operacija v splošni anesteziji in z ustrezno analgezijo;
- surgery under anaesthesia and appropriate analgesia
– vstavljanje naprav, kot so katetri, telemetrijski oddajniki in miničrpalke v splošni anesteziji;
- implantation of devices such as catheters, telemetry transmitters, minipumps under general anaesthesia
– študije z nefiziološko prehrano s kliničnimi znaki ali
- studies with unphysiological diet, with clinical signs or
– nezdravljeni diabetes mellitus;
- symptoms of untreated diabetes mellitus
– pogosti ponovljeni odvzemi vzorcev krvi ali dajanje snovi;
- frequent repeated blood sampling or administration of substances
– povzročanje strahu pri živalskih modelih;
- induction of anxiety in animal models
– testi akutne strupenosti, študije akutne tolerance; študije za ugotavljanje odmerkov, testi kronične strupenosti/kancerogenosti brez smrtnega izida;
- acute toxicity tests, acute tolerability studies; range-finding studies, chronic toxicity/carcinogenicity tests with non-lethal endpoints
– modeli krčev, npr. študije epilepsije;
- seizure models e.g. epilepsy studies
– živalski modeli nesmrtonosnih oblik raka, npr. študije ksenograftov;
- non-lethal animal models of cancer e . g . xenograft studies
Huda: stopnja teže posledic 3
Severe: Severity Grade 3
Posegi na živalih in ravnanje z njimi za namene poskusa, ki živalim povzročijo hudo do zelo hudo stisko ali pri katerih živali srednje dolgo do dolgo občutijo zmerno stisko, hudo bolečino, dolgotrajno trpljenje ali hudo poškodbo ali bistveno in trajno poslabšanje splošnega stanja.
Interventions and manipulations in animals for experimental purposes which cause the animals severe to very severe distress, or subject them to a moderately long to long-lasting episode of moderate distress, severe pain, prolonged suffering or severe injury, or significant and persistent impairment of general condition.
– smrtne bakterijske ali virusne okužbe;
- bacterial or viral lethal infections
– kronični modeli revmatoidnega artritisa;
- chronic models of rheumatoid arthritis
– gensko spremenjene živali s smrtnimi fenotipi (npr. onkogeni), brez zgodnje prekinitve poskusa;
- genetically modified animals with lethal phenotypes (e.g. oncogenes), without early termination of the experiment
– presaditev organov (npr. ledvic, trebušne slinavke);
- organ transplantation (e . g. kidney, pancreas)
Področje uporabe nove direktive
Scope of the new directive
Ker se veljavna direktiva (86/609/EGS) v posameznih državah članicah razlaga različno, je prvi cilj predloga ponovno vzpostaviti enake pogoje za industrijo in raziskovalno skupnost v celotni EU, hkrati pa „okrepiti varstvo živali, ki se še vedno uporabljajo v znanstvenih postopkih“.
As the current directive (86/609/EEC) has been interpreted differently in the various Member States, the first objective of the proposal is to re-establish a level playing field throughout the EU, for industry and the research community and "at the same time strengthening the protection of animals still used in scientific procedures".
Glede na veljavno direktivo predlog zajema varstvo živali, ki se uporabljajo za znanstvene namene, povezane z zdravjem ljudi ali živali ali dobrim počutjem živali.
As for the current directive, the proposal covers the protection of animals used for scientific purposes related to human or animal health or animal welfare.
Najpomembnejše razlike med predlogom in sedanjo direktivo so navedene v nadaljevanju.
The main differences between the proposition and the current directive are:
– Z novo direktivo bo etična presoja obvezna, hkrati pa bo za poskuse, pri katerih se uporabljajo živali, potrebna odobritev; direktiva ravno tako določa morebitno naknadno oceno.
- The new directive will make it compulsory to carry out ethical reviews and require that experiments where animals are used be subject to authorisation; it also requires an eventual retrospective assessment.
Ustanovi se stalni organ za etično presojo, vsaka država članica pa ustanovi nacionalni odbor za dobro počutje živali in etiko.
A Permanent ethical review body is created and each Member State shall establish a national animal welfare and ethics committee,
– Sedaj so vključene nekatere vrste nevretenčarjev in zarodki v zadnji tretjini razvoja, pa tudi larve in druge živali, ki se uporabljajo pri osnovnih raziskavah, izobraževanju in usposabljanju.
- Specific invertebrate species and foetuses in their last trimester of development and also larvae and other animals used in basic research, education and training are now included;
– Živali se lahko uporabljajo v postopkih le, če so bile te živali posebej vzrejene za uporabo v postopkih; poleg tega direktiva zahteva, da se uporabljajo samo živali druge ali kasnejše generacije, pri čemer veljajo prehodna obdobja, da se prepreči odvzem živali iz divjine in izčrpavanje prostoživečih populacij.
- Animals may only be used in procedures where those animals have been bred specifically for use in procedure, the directive also requires that only animals of second or older generations be used, subject to transitional periods to avoid taking animals from the wild and exhausting wild populations,
– Namesto poskusov na živalih je treba uporabiti alternative, če so na voljo, ter čim bolj zmanjšati število živali, ki se uporabljajo pri projektih.
- Alternatives to testing on animals must be used when available and the number of animals used in projects be reduced to a minimum.
Države članice bodo morale zagotoviti boljšo vzrejo, namestitev in oskrbo ter izboljšanje metod, ki se uporabljajo v postopkih, tako da se odpravijo ali zmanjšajo na minimum morebitne bolečine, trpljenje, stiska ali trajne poškodbe, povzročene živalim.
Member States will be required to improve the breeding, accommodation and care measures and methods used in procedures so as to eliminate or reduce to a minimum any possible pain, suffering, distress or lasting harm caused to animals.
Ti ukrepi temeljijo na načelu nadomestitve, zmanjšanja in izboljšanja uporabe živali pri poskusih.
These measures are based on the three "R" principle of replacing, reducing and refining the use of animals in experiments,
– Vsi postopki se izvajajo v splošni ali lokalni anesteziji ter so razvrščeni glede na stopnjo morebitne bolečine, trpljenja, stiske itd.
- All procedures are carried out under general or local anaesthesia and all procedures are classified in function of the degree of potential pain, suffering, distress etc.
Osnutek poročila Komisije odločno podpira, da se pri vprašanju uporabe živali pri znanstvenih poskusih oblikuje pristop, ki bi bil bolj združljiv z dobrim počutjem živali.
The Draft Commission report strongly supports the development of a more animal welfare friendly approach to the issue of the use of animals in scientific experimentation.
To kaže, da je Komisija zavezana končnemu cilju odprave poskusov na živalih.
This demonstrates the commission's commitment towards the end goal of the abolition of animal experimentation.
Evropska unija bi si morala prizadevati za uresničitev tega cilja, Evropski parlament pa je jasno izrazil svoje prepričanje, da je treba narediti več za dosego končnega cilja, torej umika živali iz znanstvenih poskusov nasploh.
The European Union should be working towards this goal and the European Parliament has made it clear that it believes that more should be done towards the final objective of removing animals from scientific experiments altogether.
Čeprav to ostaja končni cilj, zaenkrat še ni mogoče povsem odpraviti poskusov na živalih.
However, whilst this remains the end goal, we are not yet in a position to end animal experimentation altogether.
Še vedno obstaja velika praznina v razvoju alternativnih metod za poskuse brez uporabe živali, vendar bi bilo kljub temu nespametno in potencialno nevarno za zdravje ljudi določiti datum, po katerem ne bi bilo več mogoče izvajati poskusov na živalih ali poskusov na določenih skupinah živali, kot so primati razen človeka.
There remains a huge gap in the development of alternative, non animal testing methods and whilst this remains the case, it would be unwise and potentially disastrous for human health to mandate a date beyond which animal testing or testing on certain categories of animals, such as non human primates, can no longer be carried out.
Raziskave javnega mnenja zvečine kažejo podporo temu pristopu.
Public opinion polls tend to support this approach.
Tako je namen poročila Komisije izboljšati pogoje za dobro počutje živali, hkrati pa so poskusi na živalih še naprej dovoljeni.
The Commission report therefore aims to improve animal welfare conditions within the framework of continuing to allow animal experimentation.
Vendar je besedilo pogosto dvoumno in ima lahko nasproten učinek, kot ga želi doseči Komisija.
However in many instances the wording is ambiguous and may have the opposite effect to that which the Commission is seeking.
Predlog Komisije tako ni dovolj jasen, kdaj je dovoljeno uporabiti živali ali kakšne so obveznosti ustanov, ki izvajajo poskuse.
The Commission proposal is also not clear with regards to when animals can be used or the obligations on facilities carrying out tests.
V nespremenjeni obliki bi bil osnutek predloga dovolj nejasen, da bi lahko pomenil, da je izvajanje poskusov v Evropski uniji skoraj nemogoče.
If left unaltered, the draft proposal is ambiguous enough that it may mean that it becomes virtually impossible for tests to be carried out within the European Union.
Evropsko raziskovanje je že zdaj zelo konkurenčno; treba je zagotoviti, da ohranimo in izboljšamo že visoke standarde za dobro počutje živali, hkrati pa je treba zagotoviti, da bo evropska raziskovalna industrija še naprej konkurenčna na svetovni ravni.
European research is already hugely competitive and whilst ensuring that we maintain and improve the already high animal welfare standards, we must also ensure that our research industry can remain globally competitive.