natgillin/translations-raw huggingface dataset:
Member States shall evaluate the possibility of exposure of other humans (workers exposed after the application of the plant protection product, such as re-entering workers, or bystanders) or animals to the micro-organism and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use.
Države članice ocenijo možnost izpostavljenosti drugih ljudi (delavcev, izpostavljenih po nanosu fitofarmacevtskega sredstva, kot so npr. delavci, ki ponovno vstopajo, ali drugih navzočih oseb) ali živali mikroorganizmu in/ali drugim toksikološko relevantnim spojinam v fitofarmacevtskem sredstvu pri predlaganih pogojih uporabe.
the medical data and the toxicity, infectivity and pathogenicity studies provided for in part B of the Annex to Regulation (EU) No 544/2011, and the results of the evaluation thereof.
zdravstveni podatki in študije o toksičnosti, kužnosti in patogenosti iz dela B Priloge k Uredbi (EU) št. 544/2011 in rezultati njihove ocene.
Parameters that indicate the absence of ability to persist and multiply in the host, and the absence of ability to produce non-adverse or adverse effects in a host, include rapid and complete clearance from the body, no activation of the immune system, no histopathological changes, and inability to replicate at mammalian body temperatures.
Parametri, ki kažejo na nezmožnost obstoja in razmnoževanja v gostitelju ter na nezmožnost povzročanja neškodljivih ali škodljivih učinkov v gostitelju, vključujejo hitro in popolno izginitev iz telesa, neaktiviranje imunskega sistema, odsotnost histopatoloških sprememb ter nezmožnost razmnoževanja pri telesnih temperaturah sesalcev.
Evaluation based on relevant parameters of Tier 1 tests shall lead to an assessment of the possible effects of occupational exposure, taking into account the intensity and duration of exposure, including exposure due to repeated use during practical use.
Ocena na podlagi ustreznih parametrov testov na stopnji 1 vodi do ocene možnih učinkov zaradi poklicne izpostavljenosti ob upoštevanju intenzivnosti in trajanja izpostavljenosti, vključno z izpostavljenostjo zaradi ponovljene uporabe med praktično uporabo.
other relevant information on the plant protection product as provided for in part B of the Annex to Regulation (EU) No 545/2011, such as:
druge relevantne informacije o fitofarmacevtskem sredstvu iz dela B Priloge k Uredbi (EU) št. 545/2011, kot so:
excess remaining on plants and plant products after treatment, taking into account the influence of factors such as temperature, UV light, pH and the presence of certain substances,
čezmerni ostanki na rastlinah in rastlinskih proizvodih po tretiranju ob upoštevanju vpliva dejavnikov, kot so temperatura, UV-svetloba, pH in prisotnost nekaterih snovi,
Viruses and viroids should be considered as viable residues since they are capable of transferring genetic material, although strictly speaking they are not living.
Viruse in viroide je treba obravnavati kot aktivne ostanke, saj so zmožni prenašati genski material (čeprav dejansko ne živijo).
Member States shall evaluate the possibility of exposure of humans or animals to non-viable residues and their degradation products via the food chain due to the possible occurrence of such residues in or on edible parts of treated crops.
Države članice ocenijo možnost izpostavljenosti ljudi ali živali neaktivnim ostankom in njihovim razgradnim produktom pri prehranski verigi zaradi možnega pojava takih ostankov v/na užitnih delih tretiranih kultur.
the stage of development of the micro-organism at which non-viable residues are produced,
stopnjo razvoja mikroorganizma, ko se tvorijo neaktivni ostanki,
the development stages/life cycle of the micro-organism under typical environmental conditions; in particular, attention shall be paid to the assessment of the likelihood of survival and multiplication of the micro-organism in or on crops, food or feed, and, as a consequence, the likelihood of the production of non-viable residues,
razvojne faze/življenjski cikel mikroorganizma v značilnih okoljskih razmerah; zlasti je treba pozorno oceniti verjetnost preživetja in razmnoževanja mikroorganizma v kulturah, živilih ali krmi ali na njih ter posledične verjetnosti nastanka neaktivnih ostankov,
the stability of relevant non-viable residues (including the effects of factors such as temperature, UV light, pH and the presence of certain substances),
stabilnost pomembnih neaktivnih ostankov (vključno z učinki dejavnikov, kot so temperatura, UV-svetloba, pH in prisotnost nekaterih snovi),
any experimental study showing whether or not relevant non-viable residues are translocated in plants,
vse eksperimentalne študije, ki kažejo, ali se relevantni neaktivni ostanki v rastlinah premeščajo,
data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses) and additional data on application as provided for in part B of the Annex to Regulation (EU) No 545/2011,
podatke o predlagani dobri kmetijski praksi (vključno s številom in časovnim razporedom nanašanja, največjim uporabljenim odmerkom in najmanjšo uporabo škropiva pri nanašanju, predlaganimi karencami pred spravilom za predvidene uporabe ali obdobji prepovedi uporabe ali obdobji shranjevanja pri uporabi po spravilu) in dodatne podatke o nanašanju iz dela B Priloge k Uredbi (EU) št. 545/2011,
where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same residues, and
kadar je relevantno, druge registrirane uporabe fitofarmacevtskih sredstev na območju predvidene uporabe, ki vsebujejo enake ostanke, in
Member States shall evaluate the toxicity of non-viable residues and their degradation products having regard in particular to the specific information provided in accordance with part B of the Annex to Regulation (EU) No 544/2011 and in part B of the Annex to Regulation (EU) No 545/2011.
Države članice ocenijo toksičnost neaktivnih ostankov in njihovih razgradnih produktov zlasti ob upoštevanju nekaterih informacij iz dela B Priloge k Uredbi (EU) št. 544/2011 in dela B Priloge k Uredbi (EU) št. 545/2011.
Where non-viable residues or their degradation products are considered toxicologically relevant for humans and/or animals and when exposure is not considered negligible, the actual levels in or on the edible parts of treated crops shall be determined, taking into consideration:
Kadar so neaktivni ostanki ali njihovi razgradni produkti toksikološko relevantni za ljudi in/ali živali in kadar izpostavljenost ni zanemarljiva, se določijo dejanske stopnje v užitnih delih tretiranih kultur ali na njih ob upoštevanju:
analytical methods for the non-viable residues,
analitskih metod za neaktivne ostanke,
the production/formation of non-viable residues at relevant moments (e.g. at the anticipated harvest time).
nastanek/tvorbo neaktivnih ostankov v relevantnih trenutkih (npr. ob predvidenem času spravila pridelka).
Member States shall evaluate the possibility of exposure of humans or animals to viable residues via the food chain due to the possible occurrence of such residues in or on edible parts of treated crops.
Države članice ocenijo možnost izpostavljenosti ljudi ali živali aktivnim ostankom pri prehranski verigi zaradi možnega pojava takih ostankov v užitnih delih tretiranih kultur ali na njih.
the likelihood of survival, the persistence and multiplication of the micro-organism in or on crops, food or feed.
verjetnost preživetja, obstojnost in razmnoževanje mikroorganizma v kulturah, živilih ali krmi ali na njih.
The various development stages/life cycle of the micro-organism shall be addressed,
Obravnavajo se različne razvojne faze/življenjski ciklus mikroorganizma,
information on fate and behaviour in the various parts of the environment,
informacije o končnem stanju in obnašanju v različnih delih okolja,
the natural occurrence of the micro-organism (and/or a related micro-organism),
naravna prisotnost mikroorganizma (in/ali sorodnih mikroorganizmov),
data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods in the case of post-harvest uses) and additional data on application as provided for in part B of the Annex to Regulation (EU) No 545/2011,
podatki o predlagani dobri kmetijski praksi (vključno s številom in časovnim razporedom nanašanja, največjim uporabljenim odmerkom in najmanjšo uporabo škropiva pri nanašanju, predlaganimi karencami pred spravilom za predvidene uporabe ali obdobji prepovedi uporabe ali obdobji shranjevanja pri uporabi po spravilu) in dodatne podatke o nanašanju iz dela B Priloge k Uredbi (EU) št. 545/2011,
where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same micro-organism or which result in the same residues.
kadar je relevantno, druge registrirane uporabe fitofarmacevtskih sredstev na območju predlagane uporabe, ki vsebujejo enak mikroorganizem ali tvorijo enake ostanke.
Member States shall evaluate the specific information concerning the ability of viable residues to persist or grow in the host and the ability of such residues to cause effects/reactions in the host.
Države članice ocenijo nekatere informacije o zmožnosti aktivnih ostankov, da obstanejo ali rastejo v gostitelju, ter njihovo zmožnost delovanja/povzročanja reakcij v gostitelju.
In particular, the following information shall be taken into account:
Upoštevati je treba zlasti naslednje informacije:
the medical data and toxicity, infectivity and pathogenicity studies provided for in part B of the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof,
zdravstvene podatke in študije o toksičnosti, kužnosti in patogenosti iz dela B Priloge k Uredbi (EU) št. 544/2011 in rezultate njihove ocene,
the development stages/life cycle of the micro-organism under typical environmental conditions (e.g. in or on the treated crop),
razvojne faze/življenjski cikel mikroorganizma v značilnih okoljskih razmerah (npr. v tretiranih kulturah ali na njih),
The various development stages/life cycle of the micro-organism shall be addressed.
Obravnavajo se različne razvojne faze/življenjski ciklus mikroorganizma.
In the event that viable residues are considered to be toxicologically relevant for humans and/or animals and if exposure is not considered negligible, the actual levels in or on the edible parts of treated crops shall be determined, taking into consideration:
Kadar so aktivni ostanki toksikološko relevantni za ljudi in/ali živali in če izpostavljenost ni zanemarljiva, se določijo dejanske stopnje v užitnih delih tretiranih kulturah ali na njih ob upoštevanju:
analytical methods for the viable residues,
analitskih metod za aktivne ostanke,
the possibilities of extrapolating data from one crop to another.
možnosti ekstrapolacije podatkov z ene kulture na drugo.
Information on the origin and properties (e.g. specificity) of the micro-organism/its residual metabolites/toxins and its intended use forms the basis for an assessment of environmental fate and behaviour.
Informacije o izvoru in lastnostih (npr. specifičnosti) mikroorganizma/ostankov njegovih metabolitov/toksinov ter njegova nameravana uporaba so podlaga za oceno njegovega končnega stanja in obnašanja v okolju.
The mode of action of the micro-organism shall be taken into consideration.
Upošteva se način delovanja mikroorganizma.
An assessment shall be made of the fate and behaviour of any known relevant metabolite that is produced by the micro-organism.
Oceni se končno stanje in obnašanje vseh znanih relevantnih metabolitov, ki jih tvori mikroorganizem.
The assessment shall be made for each environmental compartment, and shall be triggered on the basis of the criteria specified in section 7 (iv) of part B of the Annex to Regulation (EU) No 544/2011.
Oceni se vsak del okolja posebej, ocena pa se izvede po merilih iz oddelka 7(iv) dela B Priloge k Uredbi (EU) št. 544/2011.
In the assessment of the environmental fate and behaviour of plant protection products, Member States shall have regard to all aspects of the environment, including biota.
Države članice pri oceni končnega stanja in obnašanja fitofarmacevtskih sredstev v okolju upoštevajo vse vidike okolja, vključno z biotičnimi.
The potential for persistence and multiplication of micro-organisms has to be assessed in all environmental compartments unless it can be justified that particular micro-organisms shall not reach a specific compartment.
Možnost preživetja in razmnoževanja mikroorganizmov je treba oceniti v vseh delih okolja, razen če se lahko utemelji, da posamezni mikroorganizmi ne dosežejo posebnega dela.
Member States shall evaluate the possibility of contamination of ground water, surface water and drinking water under the proposed conditions of use of the plant protection product.
Države članice ocenijo možnost onesnaženja podtalnice, površinske vode in pitne vode pri predlaganih pogojih uporabe fitofarmacevtskega sredstva.
In the overall assessment, Member States shall pay particular attention to potential adverse effects on humans through groundwater contamination, when the active substance is applied in regions with vulnerable conditions, such as drinking water abstraction areas.
Pri skupni oceni države članice so zlasti pozorne na možne škodljive učinke na ljudi pri onesnaženi podtalnici, kadar se aktivna snov nanaša na občutljivih območjih, na primer zajetjih pitne vode.
A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators.
Mikroorganizem zaradi zmožnosti, da se z razmnoževanjem ustali v okolju, lahko poveča tveganje, saj ima na ta način lahko dolgotrajen ali trajen učinek na mikrobiološke skupnosti ali njihove plenilce.
the biological properties of the micro-organism;
biološke lastnosti mikroorganizma;
the survival of the micro-organism in the environment;
preživetje mikroorganizma v okolju;
its ecological niche;
njegova ekološka niša;
the natural background level of the micro-organism, where it is indigenous;
raven naravnega ozadja mikroorganizma, kjer je avtohton;
information on fate and behaviour in the various parts of the environment;
informacije o končnem stanju in obnašanju v različnih delih okolja;
where relevant, information on potential interference with analytical systems used for the control of the quality of drinking water as provided for in Council Directive 98/83/EC [13];
kadar je relevantno, informacije o možni interferenci z analitskimi sistemi za nadzor kakovosti pitne vode, kot so določeni v Direktivi Sveta 98/83/ES [13];
where relevant, other authorised uses of plant protection products in the area of envisaged use, e.g. containing the same active substance or which gives rise to the same residues.
kadar je relevantno, podatki o drugih registriranih fitofarmacevtskih sredstvih na območju predlagane uporabe, npr. o tistih, ki vsebujejo enako aktivno snov ali tvorijo enake ostanke.
Member States shall evaluate the possibility of exposure of organisms in the atmosphere to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the risk for the atmosphere.
Države članice ocenijo možnost izpostavljenosti organizmov v ozračju fitofarmacevtskemu sredstvu pri predlaganih pogojih uporabe; če ta možnost obstaja, ocenijo tveganje za ozračje.
The transport, short-range and long-range, of the micro-organism in the atmosphere shall be taken into account.
Upošteva se bližnji ali daljni prenos mikroorganizma v ozračju.
Member States shall evaluate the possibility of exposure of organisms in the terrestrial compartment to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the risks arising for the terrestrial compartment.
Države članice ocenijo možnost izpostavljenosti kopenskih organizmov fitofarmacevtskemu sredstvu pri predlaganih pogojih uporabe; če ta možnost obstaja, ocenijo tveganje za kopenski del okolja.
Information on the ecology of the micro-organism and effects on the environment shall be assessed as well as possible exposure levels and the effects of its relevant metabolites/toxins.
Ocenijo se informacije o ekologiji mikroorganizma in vplivih na okolje ter možne stopnje izpostavljenosti in vplivi njegovih pomembnih metabolitov/toksinov.
An overall assessment of the environmental risks that the plant protection product may cause, taking into account the normal levels of exposure to micro-organisms both in the environment as well as in the body of organisms, is necessary.
Potrebna je skupna ocena tveganja za okolje, ki ga lahko povzroči fitofarmacevtsko sredstvo, ob upoštevanju običajnih stopenj izpostavljenosti mikroorganizmom v okolju in v telesu organizmov.
Member States shall evaluate the possibility of exposure of non-target organisms under the proposed conditions of use and if this possibility exists they shall evaluate the risks arising for the non-target organisms concerned.
Države članice ocenijo možnost izpostavljenosti neciljnih organizmov pri predlaganih pogojih uporabe, in če ta možnost obstaja, ocenijo tveganja za zadevne neciljne organizme.
Where applicable, an assessment of infectivity and pathogenicity is necessary, unless it can be justified that non-target organisms shall not be exposed.
Kadar je ustrezno, je treba oceniti kužnost in patogenost, razen če se lahko utemelji, da neciljni organizmi ne bodo izpostavljeni.
To assess the possibility of exposure the following information shall also be taken into consideration:
Pri oceni možnosti za izpostavljenost se upoštevajo naslednji podatki:
the survival of the micro-organism in the respective compartment;
preživetje mikroorganizma v zadevnem delu okolja;
where relevant, other authorised uses of the plant protection product in the area of envisaged use containing the same active substance or which give rise to the same residues.
kadar je relevantno, druge registrirane uporabe fitofarmacevtskega sredstva na območju predvidene uporabe, ki vsebuje enako aktivno snov ali tvori enake ostanke.
Member States shall evaluate the possibility of exposure of and effects on terrestrial wildlife (non-domestic birds, mammals and other terrestrial vertebrates).
Države članice ocenijo možnost izpostavljenosti in vpliva na kopenske divje živali (divje ptice, sesalce in druge kopenske vretenčarje).
A micro-organism may give rise to risks because of its potential to infect and multiply in avian and mammalian host systems.
Mikroorganizem lahko povzroči tveganje zaradi možnosti okužbe in razmnoževanja v gostiteljskih sistemih ptic in sesalcev.
Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:
Oceni se, ali se ugotovljeno tveganje lahko spremeni zaradi formulacije fitofarmacevtskega sredstva, pri tem pa se upoštevajo naslednje informacije o mikroorganizmu:
its mode of action;
njegov način delovanja;
other biological properties;
druge biološke lastnosti;
studies on mammalian toxicity, pathogenicity and infectivity;
študije o toksičnosti, patogenosti in kužnosti pri sesalcih;
studies on avian toxicity, pathogenicity and infectivity.
študije o toksičnosti, patogenosti in kužnosti pri pticah.
For the assessment of such effects, the following information shall be taken into consideration:
Pri oceni takih učinkov se upoštevajo naslednji podatki:
studies on mammalian toxicity;
študije o toksičnosti pri sesalcih;
studies on avian toxicity;
študije o toksičnosti pri pticah;
information on fate and behaviour in the various parts of the environment.
informacije o končnem stanju in obnašanju v različnih delih okolja.
If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the LD50 value and the estimated exposure expressed in mg/kg body weight.
Če testi pokažejo pogin ali znake zastrupitve, mora ocena vključevati izračun razmerja med toksičnostjo in izpostavljenostjo, ki temelji na količniku LD50 in ocenjeni izpostavljenosti, izraženi v mg/kg telesne teže.
A micro-organism may give rise to risks because of its potential to infect and multiply in aquatic organisms.
Mikroorganizem lahko povzroči tveganje zaradi možnosti okužbe in razmnoževanja v vodnih organizmih.
studies on toxicity, pathogenicity and infectivity.
študije o toksičnosti, patogenosti in kužnosti.
For the assessment of such effects the following information shall be taken into consideration:
Pri oceni takih učinkov se upoštevajo naslednje informacije:
studies on toxicity to aquatic organisms;
študije o toksičnosti za vodne organizme;
A micro-organism may give rise to risks because of its potential to infect and multiply in bees.
Mikroorganizem lahko povzroči tveganje zaradi možnosti okužbe in razmnoževanja v čebelah.
studies on toxicity to bees;
študije o toksičnosti za čebele;
Member States shall evaluate the possibility of exposure of and effects on arthropods other than bees.
Države članice ocenijo možnost izpostavljenosti in vpliva na druge členonožce razen čebel.
A micro-organism may give rise to risks because of its potential to infect and multiply in arthropods other than bees.
Mikroorganizem lahko povzroči tveganje zaradi možnosti okužbe in razmnoževanja v drugih členonožcih razen čebelah.
studies on toxicity, pathogenicity and infectivity to honeybees and other arthropods.
študije o toksičnosti, patogenosti in kužnosti za medonosne čebele in druge členonožce.
studies on toxicity to arthropods;
študije o toksičnosti za členonožce;
available data from biological primary screening.
dostopni podatki iz primarnega biološkega presejanja.
A micro-organism may give rise to risks because of its potential to infect and multiply in earthworms.
Mikroorganizem lahko povzroči tveganje zaradi možnosti okužbe in razmnoževanja v deževnikih.
studies on earthworm toxicity, pathogenicity and infectivity.
študije o toksičnosti, patogenosti in kužnosti za deževnike.
studies on earthworm toxicity;
študije o toksičnosti za deževnike;
A micro-organism may give rise to risks because of its potential to interfere with nitrogen and carbon mineralisation in the soil.
Mikroorganizem lahko povzroči tveganje zaradi možnosti motenja mineralizacije dušika in ogljika v tleh.
Member States shall evaluate the impact of exotic/non-indigenous micro-organisms on non-target micro-organisms and on their predators following use of the plant protection product in accordance with the proposed conditions of use.
Države članice ocenijo učinek eksotičnih/neavtohtonih mikroorganizmov na neciljne mikroorganizme ter na njihove plenilce po uporabi fitofarmacevtskega sredstva pod predlaganimi pogoji uporabe.
Member States shall draw conclusions on the need for further information and/or testing and the need for measures to limit the risks arising.
Države članice sprejmejo sklepe o potrebi po dodatnih informacijah in/ali testih ter ukrepih za omejitev tveganja.
Where appropriate, Member States shall impose conditions or restrictions on the authorisations they grant.
Kadar je ustrezno, države članice v postopku registracije določijo pogoje ali omejitve uporabe fitofarmacevtskega sredstva.
The nature and severity of these conditions or restrictions must be selected on the basis of, and be appropriate to, the nature and extent of the expected advantages and the risks likely to arise.
Vrsta in strogost teh pogojev ali omejitev se morata določiti na podlagi vrste in obsega pričakovanih prednosti in možnega tveganja ter morata biti tudi temu primerna.