natgillin/translations-raw huggingface dataset:
Vendar morajo vseeno imeti pozitivno etično oceno.
These projects should, however, be subject to favourable ethical evaluation.
Gre za spoštovanje načela enakosti in jamstvo za spoštovanje dobrega počutja živali.
The issues at stake are compliance with the principle of equal treatment and guaranteeing that due consideration is given to animal welfare.
Odgovorna znanstvena oseba ali odgovorna oseba uporabniške enote , kjer se vodi projekt, predloži vlogo za odobritev projekta, ki vključuje:
The scientific director or the person in charge of the establishment where the project is to be carried out shall submit an application for the project authorisation, which shall include the following:
Treba je upoštevati možnost, da je uporabniška enota za poskuse skupna za mnoge laboratorije, kot se to pogosto dogaja pri akademskih raziskavah.
It is important to take account of the fact that it often happens in academic research that a number of laboratories have common experimentation establishments.
Člen 36 – odstavek 1 – točka (c a) (novo)
Article 36 – paragraph 1 – point c a (new)
Za preučitev vloge so ti podatki nujni.
This information is essential in order to assess the application.
Člen 37 – odstavek 2 – točka d
Article 37 – paragraph 2 – point d
(d) analizo škode in koristi projekta, da se oceni, ali škodo, povzročeno živalim s trpljenjem, bolečino in stisko, ter kadar je to ustrezno, okolju etično sprejemljiv pričakovani napredek znanosti, ki nazadnje koristi ljudem, živalim ali okolju;
(d) a harm-benefit analysis of the project, to assess whether the harm to the animals in terms of suffering, pain and distress, and to the environment, where appropriate, is ethically defensible in the light of the expected advancement of science that ultimately benefits human beings, animals or the environment;
Analiza škode in koristi na podlagi objektivnih, znanstveno priznanih merilih ni izvedljiva in ne upošteva narave znanosti.
It is impossible to carry out a harm-benefit analysis on the basis of objective, scientifically recognised criteria, and such a requirement disregards the nature of science.
Z znanstvenimi poskusi pridobljenega znanja se ne da predhodno napovedati, saj se je v preteklosti pokazalo, da se določeni rezultati šele čez nekaj let izkažejo za koristne pri razvoju posebnih uporab za človeka, žival ali okolje.
The knowledge gained from a scientific experiment cannot be foreseen in advance, and history shows that in many cases the usefulness of certain results for the development of specific applications for human beings, animals or the environment does not become clear until years later.
The ethical assessment should therefore examine whether the project is ethically defensible.
The ethical assessment should therefore examine whether the project is ethically defensible.
This corresponds to the tried-and-tested procedure used in Germany.
This corresponds to the tried-and-tested procedure used in Germany.
Člen 37 – odstavek 3 – uvodni del
Article 37 – paragraph 3 – introductory part
Pristojni organ, ki izvaja etično vrednotenje, vključi ustrezno strokovno znanje zlasti na naslednjih področjih:
The competent authority carrying out the ethical evaluation shall consider corresponding expertise in particular in the following areas:
V etično vrednotenje bi se moralo črpati iz neodvisnega strokovnega znanja.
The ethical evaluation should draw on independent expertise.
Obstoječi predlog komisije ne upošteva, da bi lahko bilo to strokovno znanje na voljo tudi znotraj organa, ki izvaja etično vrednotenje, in da je treba zagotoviti zaupnost zadevnih informacij.
So far, the Commission proposal does not take into account that this expertise may also be available within the Committee on Ethics and that the confidentiality of the corresponding information must be guaranteed.
Etièno vrednotenje se izvaja pregledno, z vkljuèevanjem neodvisnega strokovnega znanja, ob varovanju intelektualne lastnine in zaupnih informacij ter varnosti za dobrine in ljudi .
Ethical evaluation shall be performed in a transparent manner by integrating independent expertise whilst safeguarding intellectual property and confidential information and also the safety of goods and persons.
Člen 38 – odstavek 2 – točka b
Article 38 – paragraph 2 – point b
(b) škoda, ki je bila povzročena živalim, vključno s številom in vrsto uporabljenih živali in težo posledic postopkov ;
(b) harm inflicted on animals including the numbers and species of animals used and the severity of the procedures;
(b) škoda, ki je bila povzročena živalim, vključno s številom in vrsto uporabljenih živali in vrsto, stopnjo in trajanjem škode, ki jo utrpijo živali med postopki ;
(b) harm inflicted on animals including the numbers and species of animals used and the nature, level and duration of the harm inflicted on animals during the procedures;
Ob upoštevanju varovanja zaupnih podatkov , ki zadevajo podjetje in njegovo osebje, netehnični povzetek projekta vsebuje:
Subject to safeguarding confidential information, including that of the establishment and its staff, the non-technical project summary shall provide the following:
(a) podatke o ciljih projekta, vključno z verjetnostjo, da se dosežejo, morebitno škodo in podrobnostmi o številu in vrstah živali, ki bodo uporabljene;
(a) information on the objectives of the project, including the likelihood of achieving them, the potential harm, and details of the number and types of animals to be used;
(b) dokaz, da je bila dosežena skladnost z zahtevami nadomestitve, zmanjšanja in izboljšanja.
(b) a demonstration that there has been compliance with the requirement of replacement, reduction and refinement.
Netehnični povzetki odobrenih projektov in njihove morebitne posodobitve so na zahtevo predloženi pristojnim organom, ki jih dajo na voljo javnosti .
The non-technical project summaries of authorised projects and any updates to them shall be sent, on request, to the competent authorities, which shall make them publicly available .
Treba se je izogniti administrativnim „zamaškom“, obenem pa jasno določiti, da javnost lahko dostopa do podatkov.
The aim is to avoid administrative bottlenecks, whilst clearly establishing that public access to this information is possible.
Odobritve projektov se dodelijo za obdobje, ki ne presega štirih let.
Project authorisations shall be granted for a period not exceeding four years.
Odobritve projektov se dodelijo za obdobje, ki ne presega pet let.
Project authorisations shall be granted for a period not exceeding five years.
Ne sme se prekomerno povečati administrativne obremenitve.
The aim is to avoid imposing an excessive administrative burden.
Države članice lahko dovolijo odobritev več projektov z eno skupinsko odobritvijo , kadar se ti projekti zahtevajo z zakonom.
Member States may allow the authorisation of multiple projects under one group authorisation when those projects are required by law.
Pojasnilo besedila.
Clarification of the wording.
Pristojni organ lahko na zahtevo uporabniške enote ali znanstvene osebe, odgovorne za projekt, spremeni ali podaljša odobritev projekta.
The competent authority may amend or renew the project authorisation on the request of the user establishment or the scientific director of the project .
Vsako podaljšanje odobritve projekta , ki vključuje hude postopke ali primate razen človeka ali kjer se škoda živalim zmerno ali zelo poveča, je odvisno od dodatnega ugodnega etičnega ovrednotenja in odobritve pristojnega organa .
Any renewal of a project authorisation that involves severe procedures or non-human primates, or a moderate or greater increase in animal harm shall be subject to a further favourable ethical evaluation and authorisation by the competent authority .
To bi pomenilo zelo veliko obremenitev, saj sem sodijo tudi manjše spremembe dovoljenj, ki zelo malo vplivajo na dobro počutje živali ali pa sploh ne.
This would be a very serious burden as it covers even minor amendments to licenses with no or minimal welfare impact.
Pristojni organ lahko prekliče odobritev projekta, kadar se projekt ne izvaja v skladu z odobritvijo projekta in lahko povzroči poslabšanje dobrega počutja živali .
The competent authority may withdraw the project authorisation where the project is not carried out in accordance with the project authorisation and may cause a deterioration in animal welfare .
Ne glede na odstavek 1 se v izjemnih okoliščinah in kadar je projekt večdisciplinaren, inovativen in ni rutinski, odločba o izdaji odobritve sprejme in sporoči uporabniški enoti v 60 dneh od predložitve vloge.
Notwithstanding paragraph 1, in exceptional circumstances and where the project is non-routine, multi-disciplinary and innovative , the decision to grant an authorisation shall be taken and communicated to the user establishment within 60 days from the submission of the application.
Vse vloge za poskuse na živalih morajo imeti zgornjo časovno omejitev.
A time limit must apply to all applications for animal experiments.
Za vse vloge pa mora biti možna tudi navidezna odobritev v primeru prekoračitve tega roka.
‘Constructive approval’ where this deadline has been exceeded must also apply to all applications.
V nasprotnem primeru ne bi bila zagotovljena preglednost in zakonitost postopka.
Otherwise the transparency and legality of the procedure would not be guaranteed.
Za zapletenejše vloge za poskuse na živalih rok 30 ali celo 60 dni ne zadostuje, da bi jih lahko organi in telesa ustrezno presodili.
In the case of complex applications for animal experiments, a time limit of 30 or even 60 days is not sufficient to allow authorities and bodies to carry out an appropriate assessment.
V Nemčiji se je za vse vloge ohranil rok 90 dni in že dolgo velja.
A time limit of 90 days for all applications has proved effective in Germany and has been enforced there for many years.
Komisija in države članice finančno in z vsemi drugimi primernimi sredstvi prispevajo k razvoju in , kjer je to potrebno, znanstvenemu potrjevanju alternativnih pristopov, namenjenih zagotavljanju enake ali višje ravni podatkov, kot je pridobljena pri postopkih, v katerih so uporabljene živali, ampak ne vključujejo uporabe živali ali jih uporabljajo manj ali pa vključujejo manj boleče postopke, ter bodo naredile take druge korake, za katere menijo, da so primerni za spodbujanje raziskav na tem področju.
The Commission and Member States shall contribute financially and by any other appropriate means, to the development and , where appropriate, scientific validation of alternative approaches intended to provide the same or higher level of information as that obtained in procedures using animals but that do not involve the use of animals or use fewer animals or that entail less painful procedures and shall take such other steps as they consider appropriate to encourage research in this field.
V zadnjih letih je prišlo do velikega napredka pri nadomeščanju, zmanjševanju in izboljšanju uporabe živali pri postopkih, in sicer zaradi namenskih raziskav, izmenjevanja najboljše prakse in s pomočjo validacijskih študij, izvedenih po mednarodnih standardih.
In recent years considerable progress has been made towards replacing, reducing and refining the use of animals in procedures through dedicated research, sharing of best practice and through validation studies conducted according to international standards.
Na tem področju so potrebna še večja prizadevanja, da bi spodbujali dobro počutje živali in zmanjšali njihovo trpljenje.
Efforts in this field should be increased in order to promote animal welfare and reduce animal suffering.
Komisija do [eno leto po začetku veljavnosti te direktive] okrepi vlogo Evropskega centra za validacijo alternativnih metod ter ustvari nove zmogljivosti za spodbujanje razvoja in uporabe alternativ postopkom na živalih, vključno z uporabo živali v osnovnih in uporabnih biomedicinskih raziskavah in veterinarskih raziskavah.
The Commission shall, by [one year after entry into force of this Directive], strengthen the role of the European Centre for the Validation of Alternative Methods and create new facilities to advance the development and use of alternatives to animal procedures including the use of animals in basic and applied biomedical and veterinary research.
Evropski center za validacijo alternativnih metod se usklajuje z nacionalnimi referenčnimi laboratoriji iz člena 46 z namenom, da:
The European Centre for the Validation of Alternative Methods shall coordinate with the national reference laboratories referred to in Article 46 in order to:
(a) oblikuje strategije za spodbujanje nadomestitve, zmanjšanja in izboljšanja uporabe živali v osnovnih in uporabnih biomedicinskih raziskavah ter predpisanega preskušanja;
(a) develop strategies to advance the replacement, reduction and refinement of the use of animals in basic and applied biomedical and veterinary research, and regulatory testing;
(b) opravlja in naroča raziskave za razvoj novih metod nadomestitve, zmanjšanja in izboljšanja;
(b) conduct and commission research in order to develop new replacement, reduction and refinement techniques;
(c) pristojnim organom, znanstveni skupnosti, javnosti in ustreznim zainteresiranim stranem zagotovi svetovanje, smernice in informacije o uporabi načela nadomestitve, zmanjšanja in izboljšanja;
(c) provide advice, guidance and information on the application of the 3Rs (replacement, reduction and refinement) to competent authorities, the scientific community, the public and relevant stakeholders;
(d) usklajuje študije predhodnega potrjevanja in potrjevanja za spodbujanje nadomestitve, zmanjšanja in izboljšanja uporabe živali v predpisanih preskusih;
(d) coordinate pre-validation and validation studies in order to further the replacement, reduction and refinement of the use of animals in regulatory testing;
(e) olajša znanstveno potrditev in regulativno sprejemanje alternativ poskusom na živalih, kar je potrebno za regulativne namene.
(e) facilitate the scientific endorsement and regulatory acceptance of alternatives to animal tests used for regulatory purposes.
Potreben je širši in bolj usklajen pristop, da bi podprli cilje iz člena 45 in uskladili pristop k raziskavam in k razvoju alternativ na vseh področjih uporabe živali ter da bi upravljali z validacijskimi študijami ter tako razširili vlogo in okrepili zmogljivosti obstoječe infrastrukture (Evropski center za validacijo alternativnih metod).
A more wide-ranging and coordinated approach is needed to further the aims of Article 45, coordinate approach to research, and the development of alternatives in all areas of animal use, as well as to manage validation studies, expanding on the role and facilities of the existing infrastructure (ECVAM).
Vsaka država članica do [eno leto po začetku veljavnosti te direktive] določi nacionalni referenčni laboratorij za potrjevanje alternativnih metod, s katerimi se nadomesti, zmanjša in izboljša uporaba živali.
Each Member State shall, by [one year after entry into force of this Directive] , designate a national reference laboratory for the validation of alternative methods replacing, reducing and refining the use of animals.
Vsaka država članica do [eno leto po začetku veljavnosti te direktive] zagotovi dostop do enega ali več akreditiranih referenčnih centrov za potrjevanje alternativnih metod, s katerimi se nadomesti, zmanjša in izboljša uporaba živali.
Each Member State shall, by [one year after entry into force of this Directive], ensure access to one or more accredited European reference centre(s) for the validation of alternative methods replacing, reducing and refining the use of animals.
Z vidika usposobljenih kadrov ni niti stroškovno učinkovito niti dosegljivo, da bi vsaka država članica ustanovila svoj referenčni laboratorij.
It is neither cost effective nor feasible from the perspective of qualified human resources for every member state to establish its own reference laboratory.
Dovolj je zahteva po dostopu do centrov po vsej EU.
It is sufficient to require access to centres on an EU-wide basis.
Tako bi tudi spodbudili izmenjavo najboljših praks.
It would also encourage the sharing of best practice.
Člen 46 – odstavek 4 – točka d
Article 46 – paragraph 4 – point d
(d) ustreznim organom znotraj držav članic in med njimi zagotavljajo znanstveno in tehnično pomoč pri sprejemanju in izvajanju alternativnih metod;
(d) provide scientific and technical assistance to the relevant authorities within and between the Member States for the acceptance and implementation of alternative methods;
Najboljša praksa bi morala biti mednarodna last.
Best practices should be international property.
Države članice objavijo in predložijo Komisiji te statistične podatke 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 [ 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 [ five 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.
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 after 10 years from the entry into force of the Directive would be unable to keep pace with technological and scientific progress.
Občutljivost nevretenčarjev, razen glavonožcev, ni bila nikoli znanstveno dokazana.
There has never been any scientific proof of the sensitivity of invertebrates other than cephalopods.
V zvezi s kunci je pomembno, da se omogoči nadaljevanje poskusov za agronomske namene (genetska izboljšava živali iz vzreje, kakovost mesa, dobro počutje živali iz vzreje itd.).
With regard to rabbits, it is essential that further experimentation be permitted for agronomic purposes (genetic improvement of production animals, quality of the meat, welfare of farmed animals, etc.).
Poleg tega bi bilo diskriminatorno, če bi zahtevali, da se živali iste vrste vzrejajo v ločenih krajih, glede na to, ali so namenjene za raziskave ali za vzrejo.
It would also be discriminatory to require that the same species be bred in separate farms depending on whether it is intended for research purposes or for production purposes.
Ribe cebrice (danio danio)
Zebrafish (Danio danio )
Ribe cebrice (danio danio) so laboratorijska vrsta z mnogimi genetskimi različicami, ki se zelo razlikujejo od prvotne prostoživeče vrste, in morajo zaradi sanitarne varnosti prihajati iz ribogojnic, namenjenih za poskuse.
With regard to the zebrafish (danio danio), this is a laboratory species with very many genetic variants which now differs significantly from the original wild species and, particularly for food safety reasons, should come from establishments breeding them for experimental purposes.
Priloga IV – točka 3 – točka 3.5 – točka a
Annex IV – point 3 – point 3.5 – point a
(a) Vsem živalim mora biti vedno na voljo nekontaminirana pitna voda .
(a) Uncontaminated drinking water shall always be available to all animals.
(a) Vsem živalim mora biti na voljo zadostna količina nekontaminirane pitne vode .
(a) Sufficient uncontaminated drinking water shall be available to all animals.
V mnogih poskusih fiziološkega odziva se tekočine (voda, sokovi itd.) uporabljajo kot okrepčilo (to pomeni kot nagrada) za poskusne živali.
Many experiments investigating behavioural physiology use liquids (water, juice, etc.) as reinforcement (i.e. as a ‘reward’) for animals used in procedures.
To je potrebno za vedenjsko pogojevanje.
This is necessary in order to condition behaviour.
Zato v takšnih poskusih živalim ne sme biti vedno na voljo tekočina.
Consequently, the animals may not ‘always’ have access to liquids in such experiments.
Čeprav se seveda zagotovi zadostna oskrba z njo.
A sufficient supply of water is of course nevertheless guaranteed.
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 so postopki, ki so boleči za ljudi, boleči tudi za živali, razen če je znano ali ugotovljeno drugače.
Unless the contrary is known or established it shall be assumed that procedures that cause pain in humans also cause pain in animals.
Brez bolečin ali blag stres/blaga bolečina: stopnja teže posledic 1
No pain or mild stress/pain: Severity Grade 1
Posegi na živalih in ravnanje z njimi za namene poskusa, zaradi katerega živali ne izkusijo bolečine ali izkusijo blago bolečino, trpljenje ali poškodbo oziroma ne izkusijo strahu ali izkusijo blag strah, njihovo splošno stanje pa se pomembno ne poslabša.
Interventions and manipulations in animals for experimental purposes as a result of which the animals experience no pain or mild pain, suffering and injury, or no anxiety or mild anxiety and no significant impairment of their general condition.
– študije z različno sestavo krme ali z nefiziološko prehrano brez očitnih kliničnih znakov ali simptomov;
- studies with differing feed compositions or with unphysiological diet, without manifest clinical signs or symptoms;
– odvzem vzorcev krvi; injekcija zdravila ( s.c., i.m., i.p., i.v.);
- withdrawal of blood samples; injection (s.c., i.m., i.p., i.v.) of a drug;
– en sam retrobulbaren vzorec krvi ali več retrobulbarnih vzorcev krvi v časovnih presledkih > 14 dni (izmenična punkcija) s kratkotrajno anestezijo;
- one single retrobulbar blood sample or several retrobulbar blood samples at intervals of > 14 days (alternating punctures), under brief anaesthesia;
– podkožno speljani venski katetri;
- subcutaneously channelled venous catheters;
– meritve jedrske magnetne resonance (NMR) z uporabo pomirjeval pri živalih ali brez nje;
- NMR measurements (nuclear spin resonance), with or without sedation of the animals;
– testiranje kontrastnih sredstev s preiskovalnim ultrazvokom;
- test of contrast media by means of exploratory echography;
– aplikacija snovi z znanimi neškodljivimi učinki (kontrolna skupina, ki prejema vehikel);
- application of substances with known innocuous effects (vehicle-control);
– študije tolerance, ki lahko povzročijo prehodne, blage, lokalne ali sistemske reakcije in ki zaradi načina dajanja snovi ali odvzema vzorcev pri živalih ne povzročajo bistvenega stresa;
- tolerability studies which give rise to transient, mild, local or systemic reactions and, owing to the method of administration or sample collection, impose no significant stress on the animals;
– bronhoskopija, bronhoalveolarna lavaža ali testiranje pljučne funkcije na anesteziranih živalih;
- bronchoscopy, broncho-alveolar lavage or pulmonary-function test in anaesthetized animals;
– modeli snemanja EKG-ja pri psih pri zavesti;
- models with ECG recordings in the conscious dog;
– test odprtega polja, testi z labirintom, test stopnic;
- open-field test, labyrinth tests, the staircase test;
– model cirkadianega ritma.
- circadian-rhythm model.
Zmeren stres: stopnja teže posledic 2
Moderate Stress: Severity Grade 2
Posegi na živalih in ravnanje z njimi za namene poskusa, pri katerih živali za kratek čas izkusijo zmeren stres ali srednje dolgo ali dolgo izkusijo blag stres (bolečino, trpljenje ali poškodbo, hud strah ali bistveno poslabšanje splošnega stanja).
Interventions and manipulations in animals for experimental purposes which subject the animals to a brief episode of moderate stress, or a moderately long to long-lasting episode of mild stress (pain, suffering, or injury, extreme anxiety, or significant impairment of general condition).
– modeli merjenja srčne frekvence s telemetrijo pri živali pri zavesti s katetri/oddajniki vsajenimi v trebušno votlino;
- models with telemetric heart-rate measurements in the conscious animal by means of catheters/transmitters implanted in the abdominal cavity;