natgillin/translations-raw huggingface dataset:
Suitable tests would need to examine interaction with DNA (such as the dominant lethal assay), to look at the potential for inherited effects and possibly make a quantitative assessment of heritable effects.
Z ustreznimi preskusi je treba preučiti interakcijo z DNK (npr. s preskusom dominantne smrtnosti) za obravnavo možnosti dednih učinkov in morebitno količinsko oceno dednih učinkov.
A summary of all data and information provided under points 5.1 through 5.5, must be submitted, and include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the data base.
Predložiti je treba povzetek vseh podatkov in informacij iz točk 5.1 do 5.5, vključno s podrobno in kritično oceno navedenih podatkov, ki temelji na ustreznih merilih ter smernicah za ocenjevanje in odločanje, pri čemer je treba obravnavati zlasti možno ali dejansko tveganje za ljudi in živali ter obseg, kakovost in zanesljivost podatkovne zbirke.
It must be explained whether exposure of animals or humans has any implications for vaccination or serological monitoring.
Pojasniti je treba, ali je zaradi izpostavljenosti živali ali ljudi kakor koli potrebno cepljenje ali serološko spremljanje.
The information provided, taken together with that for one or more preparations containing the micro-organism, must be sufficient to permit an evaluation to be made as to the risk for man and/or animals, arising from exposure to the micro-organism and its residual traces and metabolites (toxins) remaining in or on plants or plant products.
Predložene informacije, skupaj z informacijami, predloženimi za enega ali več pripravkov, ki vsebujejo mikroorganizem, morajo zadoščati za oceno tveganja za ljudi in/ali živali zaradi izpostavljenosti mikroorganizmu in njegovim ostankom ter metabolitom (toksinom), ki ostanejo v rastlinah ali rastlinskih proizvodih ali na njih.
specify appropriate conditions or restrictions to be associated with any approval
natančno opredelitev ustreznih pogojev ali omejitev v zvezi z vsako odobritvijo,
where relevant, set maximum residue levels, preharvest intervals to protect consumers and waiting periods, to protect workers handling the treated crops and products.
kadar je ustrezno, določanje mejnih vrednosti ostankov, karenc pred spravilom za zaščito potrošnikov in karenc za zaščito delavcev, ki ravnajo s tretiranimi kulturami in proizvodi.
For the evaluation of risk arising from residues, experimental data on levels of exposure to the residue may not be required where it can be justified, that the micro-organism and its metabolites are not hazardous to humans in the concentrations that could occur as a result of authorised use.
Za oceno tveganja zaradi ostankov podatki o poskusu v zvezi s stopnjami izpostavljenosti ostanku morda niso potrebni, kadar se lahko utemelji, da mikroorganizem in njegovi metaboliti v koncentracijah, ki se lahko pojavijo na podlagi registrirane uporabe, niso nevarni za ljudi.
This justification can be based on open literature, on practical experience and on information submitted in Sections 1, 2 and 3 and Section 5.
Ta utemeljitev lahko temelji na dostopni literaturi, praktičnih izkušnjah in predloženih informacijah iz oddelkov 1, 2, 3 in 5.
A substantiated estimation of persistence/competitiveness of the micro-organism and relevant secondary metabolites (especially toxins) in or on the crop under the environmental conditions prevailing at and after the intended use, taking into account in particular the information provided in Section 2, has to be delivered.
Predložiti je treba utemeljeno oceno obstojnosti/tekmovalnosti mikroorganizma in relevantnih sekundarnih metabolitov (zlasti toksinov) v kulturah ali na njih v okoljskih razmerah, ki prevladujejo med predvideno uporabo in po njej, zlasti ob upoštevanju predloženih informacij iz oddelka 2.
Moreover, the application shall state to which extent and on which basis it is considered that the micro-organism can (or cannot) multiply in or on the plant or plant product or during processing of raw products.
Poleg tega se v vlogi navede, v kakšnem obsegu in na kakšni podlagi se šteje, da se mikroorganizem lahko ali ne more razmnoževati v rastlini ali rastlinskem proizvodu ali na njiju ali med predelavo surovin.
A non viable micro-organism is a micro-organism that is not capable of replication or of transferring genetic material.
Neživi mikroorganizem je mikroorganizem, ki ni sposoben delitve ali prenašanja genskega materiala.
If relevant quantities of the micro-organism or of produced metabolites, especially toxins, have been found to be persistent in points 2.4 and 2.5, full experimental residue data as provided for in Section 6 of Part A of this Annex is required, if concentrations of the micro-organism and/or its toxins in or on the treated foodstuffs or feedingstuffs are expected to occur in concentrations higher than under natural conditions or in a different phenotypic state.
Če se za relevantne količine mikroorganizma ali nastalih metabolitov, zlasti toksinov, v točkah 2.4 in 2.5 ugotovi, da so obstojni, so potrebni izčrpni podatki iz poskusov o ostankih, kakor so določeni v oddelku 6 dela A te priloge, če se pričakuje, da bodo koncentracije mikroorganizma in/ali njegovih toksinov v tretiranih živilih ali krmi ali na njih višje kakor v naravnih pogojih ali drugačnem fenotipu.
In accordance with Regulation (EC) No 1107/2009, the conclusion concerning the difference between natural concentrations and an elevated concentration due to treatment with the micro-organism, is to be based on experimentally obtained data, and not on extrapolations or calculations using models.
V skladu z Uredbo (ES) št. 1107/2009 mora ugotovitev v zvezi z razliko med naravnimi koncentracijami in povišano koncentracijo zaradi tretiranja z mikroorganizmom temeljiti na podatkih, pridobljenih s poskusi, in ne na ekstrapolacijah ali izračunih na podlagi modelov.
If the information submitted in accordance with point 6.1 suggests persistence of relevant amounts of the micro-organism in or on treated products, food or feed, possible effects on humans and/or animals must be investigated, unless it can be justified from Section 5, that the micro-organism and its metabolites and/or degradation products are not hazardous to humans in the concentrations and of the nature that could occur as a result of authorised use.
Če informacije, predložene v skladu s točko 6.1, kažejo na obstojnost relevantnih količin mikroorganizma v tretiranih proizvodih, živilih ali krmi ali na njih, je treba preučiti morebitne učinke na ljudi in/ali živali, razen če se lahko na podlagi oddelka 5 utemelji, da koncentracije in narava mikroorganizma in njegovih metabolitov in/ali razgradnih produktov, ki bi lahko izhajale iz registrirane uporabe, niso nevarne za ljudi.
The persistence of viable residues needs special attention if infectiveness or pathogenicity to mammals has been found in points 2.3 and 2.5 or in Section 5 and/or if any other information suggests a hazard to consumers and/or workers.
Obstojnost živih ostankov je treba posebej obravnavati, če sta bili v točkah 2.3 in 2.5 ali oddelku 5 ugotovljeni kužnost ali patogenost za sesalce in/ali če kakršne koli druge informacije kažejo na nevarnost za potrošnike in/ali delavce.
In this case the competent authorities may require studies similar to those provided for in Part A.
V tem primeru lahko pristojni organi zahtevajo študije, podobne študijam iz dela A.
Information on the origin, the properties, and the survival of the micro-organism and its residual metabolites as well as its intended use form the basis for an assessment of environmental fate and behaviour.
Ocena končnega stanja in obnašanja v okolju se izvede na podlagi informacij o izvoru, lastnostih in preživetju mikroorganizma in ostankov njegovih metabolitov ter njegove predvidene uporabe.
Experimental data are normally required unless it can be justified that an assessment of its fate and behaviour in the environment can be performed with the information already available.
Podatki o poskusu so običajno potrebni, razen če se lahko utemelji, da se lahko ocena končnega stanja in obnašanja mikroorganizma v okolju izdela na podlagi razpoložljivih informacij.
This justification can be based on open literature, on practical experience and on information submitted in Sections 1 to 6.
Ta utemeljitev lahko temelji na dostopni literaturi, praktičnih izkušnjah in informacijah iz oddelkov 1 do 6.
The information provided, taken together with other relevant information, and that for one or more preparations containing the micro-organism, must be sufficient to permit an assessment of its fate and behaviour as well as that of its residual traces and toxins, where they are of significance for human health and/or the environment.
Predložene informacije, skupaj z drugimi pomembnimi informacijami in informacijami, predloženimi za enega ali več pripravkov, ki vsebujejo mikroorganizem, morajo zadoščati za oceno končnega stanja in obnašanja mikroorganizma ter tudi njegovih ostankov in toksinov, kadar so pomembni za zdravje ljudi in/ali okolje.
In particular, the information provided shall be sufficient to:
Predložene informacije morajo zadoščati zlasti za:
specify the pictograms (once introduced), signal words, and relevant hazard and precautionary statements for the protection of the environment, which are to be included on packaging (containers),
določitev piktogramov (ko bodo uvedeni), opozorilnih besed ter ustreznih stavkov o nevarnosti in previdnostnih stavkov za zaščito okolja, ki morajo biti na embalaži (posodah),
predict the distribution, fate, and behaviour in the environment of the micro-organism and its metabolites as well as the time courses involved,
predvidevanje porazdelitve, končnega stanja ter obnašanja mikroorganizma in njegovih metabolitov v okolju, ter tudi časovnih potekov v teh procesih,
Any relevant metabolites (i.e. of concern for human health and/or the environment) formed by the test organism under any relevant environmental conditions shall be characterised.
Opredelijo se lastnosti kakršnih koli relevantnih metabolitov (tj. pogojno nevarnih za zdravje ljudi in/ali okolje), ki jih v kakršnih koli relevantnih okoljskih razmerah proizvaja preskusni organizem.
If relevant metabolites are present in or produced by the micro-organism, data as outlined under Section 7 of Part A of this Annex may be required, if all of the following conditions are met:
Če so relevantni metaboliti prisotni v mikroorganizmu ali jih mikroorganizem proizvaja, je morda treba predložiti podatke, kakor so opisani v oddelku 7 dela A te priloge, če so izpolnjeni vsi naslednji pogoji:
the relevant metabolite is stable outside the micro-organism, see point 2.8, and
relevantni metabolit je stabilen zunaj mikroorganizma, glej točko 2.8,
the relevant metabolite is expected to occur in the environment in concentrations considerably higher than under natural conditions.
pričakuje se, da se relevantni metabolit v okolju pojavlja v znatno večjih koncentracijah kot v naravnih pogojih.
Before performing studies as referred to below, the applicant shall seek agreement of the competent authorities on whether studies need to be performed and, if so, the type of study to be conducted.
Pred začetkom izvajanja študij iz naslednjih poglavij vlagatelj pridobi soglasje pristojnih organov o potrebi po izvajanju študij in, če je študija potrebna, o vrsti študije, ki se bo izvajala.
Where relevant, appropriate information on the persistence and multiplication of the micro-organism, in all environmental compartments has to be given, unless it can be justified that exposure of the particular environmental compartment to the micro-organism is unlikely to occur.
Kadar je ustrezno, je treba predložiti primerne informacije o obstojnosti in razmnoževanju mikroorganizma v vseh delih okolja, razen če se lahko utemelji, da je izpostavljenost določenih delov okolja mikroorganizmu malo verjetna.
Special attention shall be given to
Posebna pozornost se nameni:
competitiveness under the environmental conditions prevailing at and after the intended use, and
tekmovalnosti v okoljskih razmerah, ki prevladujejo med predvideno uporabo in po njej, ter
Estimated levels of the specified micro-organism in a time course after use of the product under the proposed conditions of use shall be given.
Navedejo se predvidene ravni določenega mikroorganizma v časovnem poteku, ki sledi uporabi proizvoda v predlaganih pogojih uporabe.
Information on viability/population dynamics shall be reported in several cultivated and uncultivated soils representative of soils typical of the various EU regions where use exists or is anticipated.
Navedejo se informacije o sposobnosti preživetja/dinamiki populacije v več obdelanih in neobdelanih vrstah tal, reprezentativnih za tla, tipična za različne regije EU, kjer se mikroorganizem uporablja ali se bo uporabljal.
Information should be reported on viability/population dynamics in natural sediment/water systems under both dark and illuminated conditions.
Navesti je treba informacije o sposobnosti preživetja/dinamiki populacije v naravnih sistemih usedline/vode v pogojih teme in pogojih svetlobe.
In case of particular concerns for operator, worker or bystander exposure, information on the concentrations in air might be necessary.
Informacije o koncentraciji v zraku je morda treba navesti v primeru posebne zaskrbljenosti zaradi izpostavljenosti izvajalca tretiranja, delavca ali drugih navzočih oseb.
The possible spread of the micro-organism and its degradation products in relevant environmental compartments has to be evaluated, unless it can be justified that exposure of the particular environmental compartments to the micro-organism is unlikely to occur.
Oceniti je treba možnost širjenja mikroorganizma in njegovih razgradnih produktov v ustreznih delih okolja, razen če se lahko utemelji, da je izpostavljenost določenega dela okolja mikroorganizmu malo verjetna.
In this context, the intended use (e.g. field or greenhouse, application to soil or to crops), life cycle stages, including occurrence of vectors, persistence and the ability of the organism to colonise adjacent habitats are of particular interest.
V zvezi s tem so zlasti pomembni predvidena uporaba (npr. na prostem ali v rastlinjakih, nanos na tla ali kulture), faze življenjskega cikla, vključno s prisotnostjo vektorjev, obstojnostjo in zmožnostjo organizma, da kolonizira bližnje habitate.
The spread, the persistence and probable transport ranges need special attention if toxicity, infectiveness or pathogenicity has been reported or if any other information suggests possible hazard to humans, animals or to the environment.
Posebno pozornost je treba nameniti širjenju, obstojnosti in morebitnim obsegom prenosa, če je ugotovljena toksičnost, kužnost ali patogenost ali če kakršne koli druge informacije kažejo na možno nevarnost za ljudi, živali ali okolje.
In this case the competent authorities may require studies similar to those provided for in Part A. Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed.
V tem primeru lahko pristojni organi zahtevajo študije, podobne študijam iz dela A. Pred začetkom izvajanja takšnih študij vlagatelj pridobi soglasje pristojnih organov glede vrste študije, ki se bo izvajala.
The information on identity, biological properties and further information in Sections 1, 2, 3 and 7 is central to the assessment of impact on non-target species.
Za oceno učinka na neciljne vrste so bistvene informacije o opredelitvi in bioloških značilnostih ter dodatne informacije iz oddelkov 1, 2, 3 in 7.
Additional useful information may be found on fate and behaviour in the environment in Section 7 and on residue levels in plants in Section 6 which, together with information on the nature of the preparation and its manner of use, defines the nature and extent of potential exposure.
Dodatne koristne informacije v zvezi s končnim stanjem in obnašanjem v okolju so navedene v oddelku 7, v zvezi z vsebnostjo ostankov v rastlinah pa v oddelku 6, pri čemer skupaj z informacijami o naravi pripravka ter načinu njegove uporabe določajo vrsto in obseg morebitne izpostavljenosti.
Experimental data are normally required, unless it can be justified that an assessment of effects on non-target organisms can be performed with the information already available.
Podatki o poskusih so običajno potrebni, razen če se lahko utemelji, da se lahko učinki na neciljne organizme ocenijo na podlagi razpoložljivih informacij.
The choice of the appropriate non-target organisms for testing of environmental effects shall be based on the identity of the micro-organism (including the host specificity, mode of action and ecology of the organism).
Izbira primernih neciljnih organizmov za preskušanje učinkov na okolje temelji na opredelitvi mikroorganizma (vključno z natančno opredelitvijo gostitelja, načinom delovanja in ekologijo organizma).
From such knowledge it would be possible to choose the appropriate test-organisms, such as organisms closely related to the target organism.
Na podlagi teh informacij je mogoče izbrati primerne preskusne organizme, kot so organizmi, ki so bližnji sorodniki ciljnega organizma.
The information provided, taken together with that for one or more preparations containing the micro-organism, must be sufficient to permit an assessment of the impact on non-target species (flora and fauna), likely to be at risk from exposure to the micro-organism, where they are of environmental significance.
Predložene informacije, skupaj z informacijami, predloženimi za enega ali več pripravkov, ki vsebujejo mikroorganizem, morajo zadoščati za oceno učinka na neciljne vrste (flora in favna), ki bi bile verjetno ogrožene zaradi izpostavljenosti mikroorganizmu, kadar so pomembne za okolje.
Impact can result from single, prolonged or repeated exposure and can be reversible or irreversible.
Učinek je lahko posledica enkratne, dolgotrajne ali ponavljajoče se izpostavljenosti, pri čemer je lahko reverzibilen ali nereverzibilen.
In particular, the information provided for the micro-organism, together with other relevant information, and that provided for one or more preparations containing it, shall be sufficient to:
Informacije v zvezi z mikroorganizmom skupaj z drugimi pomembnimi informacijami in informacijami, predloženimi za enega ali več pripravkov, ki ga vsebujejo, zadoščajo zlasti za:
permit an evaluation of short- and long-term risks for non-target species — populations, communities, and processes — as appropriate,
oceno kratkoročnih in dolgoročnih tveganj za neciljne vrste – populacije, skupnosti ter procese – kot je primerno,
specify the precautions necessary for the protection of non-target species, and
natančno določitev varnostnih ukrepov za zaščito neciljnih vrst in
specify the pictograms (once introduced), signal words, and relevant hazard and precautionary statements for the protection of the environment, to be mentioned on packaging (containers).
določitev piktogramov (ko bodo uvedeni), opozorilnih besed ter ustreznih stavkov o nevarnosti in previdnostnih stavkov za zaščito okolja, ki morajo biti navedeni na embalaži (posodah).
There is a need to report all potentially adverse effects found during routine investigations on environmental effects, to undertake and report, where required by the competent authorities, such additional studies which may be necessary to investigate the probable mechanisms involved and to assess the significance of these effects.
Navesti je treba vse morebitne škodljive učinke, ugotovljene med rutinskimi preučevanji učinkov na okolje, ter na zahtevo pristojnih organov izvesti in navesti dodatne študije, ki so morda potrebne za preučitev morebitnih mehanizmov v teh procesih in oceno pomena takšnih učinkov.
All available biological data and information which are relevant to the assessment of the ecology profile of the micro-organism must be reported.
Navesti je treba vse razpoložljive biološke podatke in informacije, pomembne za oceno ekološkega profila mikroorganizma.
For all studies, average achieved dose in cfu/kg body weight as well as in other appropriate units must be reported.
Pri vseh študijah je treba navesti dosežen povprečen odmerek v CFU/kg telesne teže ter tudi v drugih primernih enotah.
It may be necessary to conduct separate studies for relevant metabolites (especially toxins), where these products can constitute a relevant risk to non-target organisms and where their effects cannot be evaluated by the available results relating to the micro-organism.
Izvesti je morda treba ločene študije za relevantne metabolite (zlasti toksine), kadar lahko ti produkti predstavljajo resno tveganje za neciljne organizme in kadar njihovih učinkov ni mogoče oceniti na podlagi razpoložljivih rezultatov, ki se nanašajo na mikroorganizem.
Before such studies are performed, the applicant shall seek agreement of the competent authorities on whether such studies need to be performed and, if so, the type of study to be conducted.
Pred začetkom izvajanja takšnih študij vlagatelj pridobi soglasje pristojnih organov o potrebi po izvajanju takšnih študij in, če je študija potrebna, o vrsti študije, ki se bo izvajala.
In order to facilitate the assessment of the significance of test results obtained, the same strain (or recorded origin) of each relevant species shall, where possible, be used in the various tests specified.
Za lažjo oceno pomena dobljenih rezultatov preskusa se v različnih preskusih, kadar je to mogoče, uporabi isti sev (ali organizem dokazano enakega izvora) vsake relevantne vrste.
Tests must be performed unless it can be justified that the non-target organism will not be exposed to the micro-organism.
Preskuse je treba izvesti, razen če se lahko utemelji, da neciljni organizem ne bo izpostavljen mikroorganizmu.
If it is justified that the micro-organism does not cause toxic effects or is not pathogenic or infective to vertebrates or plants, only reaction to appropriate non-target organisms must be investigated.
Če se utemelji, da mikroorganizem ne povzroča toksičnih učinkov ali ni patogen ali kužen za vretenčarje ali rastline, je treba preučiti le reakcijo na primerne neciljne organizme.
Information on effects on algal growth, growth rate and capacity to recover must be reported.
Navesti je treba informacije o učinkih na rast alg, stopnjo rasti in sposobnost obnovitve.
Information on effects on plants other than algae must be reported.
Navesti je treba informacije o učinkih na rastline, razen alg.
The selection of the test species should be related to the potential use of the plant protection products (e.g. foliar or soil application).
Izbira preskusnih vrst mora biti povezana s predvideno uporabo fitofarmacevtskih sredstev (npr. foliarni ali talni nanos).
Special attention should be given to organisms used for biological control and organisms playing an important role in integrated pest management.
Posebno pozornost je treba nameniti organizmom, ki se uporabljajo za biotično zatiranje, in organizmom, ki so pomembni pri integriranem zatiranju škodljivcev.
Expert judgement is required to decide whether additional studies are necessary.
Za odločitev o potrebi po dodatnih študijah je potrebna strokovna ocena.
Such decision will take into consideration the available information in this Section and other Sections, in particular data on the specificity of the micro-organism, and the expected exposure.
Pri takšni odločitvi se upoštevajo razpoložljive informacije iz tega oddelka in drugih oddelkov, zlasti podatki o specifičnosti mikroorganizma, in pričakovana izpostavljenost.
Useful information may also be available from the observations carried out in efficacy testing.
Uporabijo se lahko tudi informacije, pridobljene na podlagi opazovanja pri preskušanju učinkovitosti.
Special attention shall be given to organisms used in integrated crop management (ICM).
Posebna pozornost se nameni organizmom, ki se uporabljajo pri integrirani pridelavi.