natgillin/translations-raw huggingface dataset:
It should be kept in mind that the co-formulants in the plant protection product can influence the toxicity and infectiveness of a micro-organism.
Upoštevati je treba, da lahko pomožne snovi v fitofarmacevtskem sredstvu vplivajo na toksičnost in kužnost mikroorganizma.
Information on the short-term infectiveness, pathogenicity and toxicity (respiratory route) of a micro-organism is required, unless the information already provided is sufficient to assess human health effects.
Navesti je treba informacije o kratkotrajni kužnosti, patogenosti in toksičnosti (respiracijska pot) mikroorganizma, razen če že predložene informacije zadoščajo za oceno učinkov na zdravje ljudi.
This can be the case if it is demonstrated that the test material has no inhalable fraction and/or repeated exposure is not expected.
To se lahko zgodi, če se izkaže, da testna snov ne vsebuje delcev, ki se jih lahko vdihuje, in/ali večkratna izpostavljenost ni pričakovana.
Proposed treatment: first aid measures, medical treatment
Predlagano zdravljenje: ukrepi prve pomoči, zdravljenje
The first aid measures to be used in the event of infection and in the event of contamination of eyes must be provided.
Navesti je treba ukrepe prve pomoči, ki se uporabljajo v primerih okužbe in kontaminacije oči.
Therapeutic regimes for use in the event of ingestion or contamination of eyes and skin must be described in full.
Terapevtske postopke za uporabo v primeru zaužitja ali kontaminacije oči in kože je treba izčrpno opisati.
Information on resistance to antibiotics must be provided.
Navesti je treba informacije o odpornosti na antibiotike.
(END OF TIER I)
(KONEC STOPNJE I)
Specific toxicity, pathogenicity and infectiveness studies
Posebne študije o toksičnosti, patogenosti in kužnosti
In certain cases, it can be necessary to carry out supplementary studies to further clarify the adverse human effects.
V nekaterih primerih je morda treba izvesti dodatne študije za nadaljnjo pojasnitev škodljivih učinkov na ljudi.
In particular, if results from earlier studies indicate that the micro-organism may cause long-term health effects, studies on chronic toxicity, pathogenicity and infectiveness, carcinogenicity and reproductive toxicity must be carried out.
Zlasti če je na podlagi rezultatov predhodnih študij razvidno, da lahko mikroorganizem povzroča dolgoročne učinke na zdravje, je treba izvesti študije o kronični toksičnosti, patogenosti in kužnosti, rakotvornosti in reproduktivni toksičnosti.
Furthermore, where a toxin is produced, kinetic studies must be performed.
Poleg tega so v primeru produkcije toksina potrebne kinetične študije.
Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed.
Pred začetkom izvajanja takšnih študij vlagatelj pridobi soglasje pristojnih organov glede vrste študije, ki se bo izvajala.
If all the results of the in vitro studies are negative further testing must be done with consideration of other relevant information available.
Če so vsi rezultati študij in vitro negativni, je treba izvajati nadaljnje teste ob upoštevanju drugih relevantnih razpoložljivih informacij.
If either of the in vitro gene mutation tests is positive, an in vivo test to investigate unscheduled DNA synthesis or a mouse spot test must be conducted.
Če je kateri koli od teh testov in vitro za gensko mutacijo pozitiven, je treba izvesti test in vivo za preučitev nepredvidene sinteze DNK ali naključni test pri miših.
Genotoxicity — In vivo studies in germ cells
Genotoksičnost – študije in vivo na kličnih celicah
Aim of the test and test conditions
Namen testiranja in pogoji, v katerih se izvaja
See point 5.4 of Part A.
Glej točko 5.4 v delu A.
The necessity for conducting these tests will have to be considered on a case-by-case basis, taking into account other relevant information available including use and expected exposure.
Potrebo po izvajanju teh testov je treba preučiti za vsak posamezen primer, pri čemer se upoštevajo druge relevantne razpoložljive informacije skupaj z uporabo in pričakovano izpostavljenostjo.
(END OF TIER II)
(KONEC STOPNJE II)
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, skladno z relevantnimi merili in smernicami za ocenjevanje in odločanje, s posebnim poudarkom na možnem ali dejanskem tveganju za ljudi in živali ter obsegu, kakovosti in zanesljivosti podatkovne zbirke.
It must be explained whether exposure of animals or humans has any implications for vaccination or serological monitoring.
Pojasniti je treba, ali izpostavljenost živali ali ljudi kakor koli zahteva 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 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 ostajajo v rastlinah ali rastlinskih proizvodih ali na njih.
permit a decision to be made as to whether or not the micro-organism can be approved,
odločitev o odobritvi mikroorganizma,
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 to relevantno, 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 poskusni podatki o stopnjah izpostavljenosti ostanku niso potrebni, kadar se lahko utemelji, da mikroorganizem in njegovi metaboliti ne predstavljajo nevarnosti za ljudi v koncentracijah, ki se lahko pojavijo na podlagi registrirane uporabe.
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 je lahko osnovana na dostopni literaturi, praktičnih izkušnjah in predloženih informacijah iz oddelkov 1, 2, 3 in 5.
Persistence and likelihood of multiplication in or on crops, feedingstuffs or foodstuffs
Obstojnost in verjetnost razmnoževanja v kulturah, krmi in živilih ali na njih
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 tehtno oceno obstojnosti/tekmovalnosti mikroorganizma in relevantnih sekundarnih metabolitov (zlasti toksinov) v kulturah ali na njih pod okoljskimi razmerami, 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 vloga navaja, do katere mere in na kakšni podlagi se mikroorganizem lahko ali ne more razmnoževati v rastlini ali rastlinskem proizvodu ali na njiju ali med predelavo surovin.
Consumers may be exposed to micro-organisms for a considerable time as a result of the consumption of treated food commodities; potential effects on the consumers must, therefore, be derived from chronic or semi-chronic studies, so that a toxicological end point, such as the ADI, can be established for risk management.
Potrošniki so lahko mikroorganizmu izpostavljeni dlje časa zaradi uživanja tretiranih živilskih proizvodov, zato je treba morebitne učinke na potrošnike določiti na podlagi kroničnih in polkroničnih študij zato, da se za obvladovanje tveganja lahko določi toksikološke zaključke, kot je ADI.
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 testiranj 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 sklep 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 ob uporabi 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 na podlagi oddelka 5 lahko utemelji, da koncentracije in narava mikroorganizma in njegovih metabolitov ter/ali razgradnih produktov, ki bi lahko izhajale iz registrirane uporabe, niso nevarni za ljudi.
The persistence of viable residues needs special attention if infectiveness or pathogenicity to mammals have 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.
Obstojnosti živih ostankov je treba posvečati posebno pozornost, 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 tistim iz dela A.
Summary and evaluation of residue behaviour resulting from data submitted under points 6.1 and 6.2
Povzetek in ocena obnašanja ostankov na podlagi podatkov, predloženih v skladu s točkama 6.1 in 6.2
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.
Informacije o izvoru, lastnostih in preživetju mikroorganizma ter njegovih metabolnih ostankov in tudi njegova predvidena uporaba predstavljajo podlago za oceno končnega stanja in obnašanja v okolju.
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 poskusih so običajno obvezni, razen če se lahko utemelji, da se ocena končnega stanja in obnašanja mikroorganizma v okolju lahko 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 je lahko osnovana na dostopni literaturi, praktičnih izkušnjah in informacijah, predloženih v oddelkih 1 do 6.
The function of the micro-organism in environmental processes is of particular interest.
Zlasti pomembna je funkcija mikroorganizma v procesih okolja.
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 relevantnimi informacijami in informacijami 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 zlasti zadoščati za:
decide whether, or not, the micro-organism can be approved,
odločitev o odobritvi mikroorganizma,
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 in relevantnih 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 in obnašanja mikroorganizma in njegovih metabolitov v okolju, kakor tudi časovnih potekov teh procesov,
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 kakršni koli relevantni metaboliti (tj. ki vzbujajo skrb za zdravje ljudi in/ali okolje), ki jih v kakršnih koli relevantnih okoljskih razmerah proizvaja testni 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, se lahko zahteva predložitev podatkov, 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 izven mikroorganizma, glej točko 2.8, in
a toxic effect of the relevant metabolite is independent of the presence of the micro-organism, and
toksični učinek relevantnega metabolita je neodvisen od prisotnosti mikroorganizma in
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 občutno višjih koncentracijah kot v naravnih pogojih.
Available information on the relationship with naturally occurring wild type relatives shall be taken into account.
Upoštevajo se razpoložljive informacije o razmerju z naravno prisotnimi sorodnimi organizmi divje vrste.
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 tako, o vrsti študije, ki se bo izvajala.
The information from the other Sections has, also, to be taken into account.
Upoštevati je treba tudi informacije iz drugih oddelkov.
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 to relevantno, 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:
Posebno pozornost se posveča:
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, in
population dynamics in seasonally or regionally extreme climates (particularly hot summer, cold winter and rainfall) and to agricultural practices applied after intended use.
dinamiki populacije v sezonskih in regionalnih skrajnih podnebnih razmerah (zlasti vroče poletje, mrzla zima in padavine) ter kmetijskim praksam po predvideni uporabi.
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 pri 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 življenjski sposobnosti/dinamiki populacije v več obdelanih in neobdelanih tleh, 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 življenjski sposobnosti/dinamiki populacije v naravnih usedlinah/vodnih sistemih 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.
V primeru posebne zaskrbljenosti zaradi izpostavljenosti izvajalca tretiranja, delavca ali drugih navzočih, je morda treba navesti informacije o koncentraciji v zraku.
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 relevantnih 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 ciklusa, 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 have been reported or if any other information suggests possible hazard to humans, animals or to the environment.
Posebno pozornost je treba nameniti širjenju, stabilnosti in morebitnim obsegom prevoza, če se pokaže toksičnost, kužnost ali patogenost ali če kakršne koli druge informacije kažejo na verjetno 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 tistim 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.
Informacije o identiteti, bioloških značilnostih in dodatne informacije v oddelkih 1, 2, 3 in 7 so bistvenega pomena za oceno vpliva na neciljne vrste.
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, ki skupaj z informacijami o naravi pripravka in načinu njegove uporabe določajo vrsto in obseg morebitne izpostavljenosti.
The information submitted in accordance with Section 5 will provide essential information as to effects to mammals and the mechanisms involved.
Informacije, predložene v skladu z oddelkom 5, bodo zagotovile bistvene informacije o učinkih na sesalce in mehanizmih v teh procesih.
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 obvezni, razen če se lahko utemelji, da se lahko učinki na neciljne organizme ocenijo na podlagi že 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 testiranje učinkov na okolje temelji na identiteti mikroorganizma (vključno z natančno opredelitvijo gostitelja, načinom delovanja in ekologije organizma).
From such knowledge it would be possible to choose the appropriate test-organisms, such as organisms closely related to the target organism.
S pomočjo tovrstnih dognanj je mogoče izbrati primerne testne 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.
Kadar so pomembne za okolje, morajo informacije, predložene skupaj z informacijami o enem ali več pripravkih, ki vsebujejo mikroorganizem, zadoščati za oceno vpliva na neciljne vrste (flora in favna), ki bi bile verjetno ogrožene zaradi izpostavljenosti mikroorganizmu.