natgillin/translations-raw huggingface dataset:
the agricultural and environmental (including climatic) conditions (if necessary for acceptable efficacy such data/information should also be given for the time before and after application);
razmere kmetijske pridelave in okolja (vključno s podnebnimi razmerami) (po potrebi je treba za sprejemljivo učinkovitost predložiti take podatke/informacije tudi o času pred nanašanjem in po njem);
the presence and density of the harmful organism;
prisotnost in gostota škodljivega organizma;
the development stage of crop and organism;
razvojna stopnja kulture in organizma;
the amount of the microbial plant protection product used;
količina uporabljenega mikrobiološkega fitofarmacevtskega sredstva;
if required on the label, the amount of adjuvant added;
količina dodanega dodatka, če se zahteva na oznaki;
the frequency and timing of the applications;
pogostost in časovni razpored nanašanja;
the type of application equipment;
vrsta opreme za nanašanje;
the need for any special cleaning measures for the application equipment.
potreba po kakršnih koli posebnih ukrepih za čiščenje opreme za nanašanje.
Member States shall evaluate the performance of the plant protection product under the range of agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use.
Države članice ocenijo delovanje fitofarmacevtskega sredstva v različnih razmerah kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami), ki so verjetni v praksi na območju predlagane uporabe.
The effect on integrated control shall be included in the evaluation.
V oceno se vključi učinek na integrirano varstvo.
In particular, consideration shall be paid to:
Preuči se zlasti:
the level, consistency and duration of the effect sought in relation to the dose in comparison with a suitable reference product or products, where they exist, and an untreated control;
stopnja, doslednost in trajanje želenega vpliva glede na odmerek v primerjavi z ustreznim referenčnim sredstvom ali sredstvi (kadar obstajajo) ter kontrolo netretiranih rastlin;
where relevant, the effect on yield or reduction of loss in storage, in terms of quantity and/or quality, in comparison with a suitable reference product or products, where they exist, and an untreated control.
kadar je relevantno, vpliv na pridelek ali količinsko in/ali kakovostno zmanjšanje izgub pri skladiščenju v primerjavi z ustreznim referenčnim sredstvom ali sredstvi (kadar obstajajo) in kontrolo netretiranih rastlin.
Where no suitable reference product exists, Member States shall evaluate the performance of the plant protection product to determine whether there is a consistent and defined benefit under the agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use.
Kadar ni ustreznega referenčnega sredstva, države članice ocenijo delovanje fitofarmacevtskega sredstva, da ugotovijo, ali njegova uporaba prinaša trajno in določljivo korist v razmerah kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami), ki so verjetni v praksi na območju predlagane uporabe.
other relevant information on the plant protection product such as nature of the plant protection product, dose, method of application, number and timing of applications, incompatibility with other crop treatments;
drugi relevantni podatki o fitofarmacevtskem sredstvu, kot so narava fitofarmacevtskega sredstva, odmerek, način nanašanja, pogostost in čas nanašanja, nezdružljivost z drugimi sredstvi za tretiranje kultur;
all relevant information on the micro-organism, including biological properties e.g. mode of action, survival, host specificity.
vse relevantne informacije o mikroorganizmu, vključno z biološkimi lastnostmi, tj. načinom delovanja, preživetjem, specifičnostjo gostitelja.
the nature, frequency, level and duration of observed phytotoxic/phytopathogenic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them;
naravo, pogostost, stopnjo in trajanje ugotovljenih fitotoksičnih/fitopatogenih učinkov ter razmere kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami), ki vplivajo nanje;
differences between main cultivars with regard to their sensitivity to phytotoxic/phytopathogenic effects;
razlike med glavnimi kultivarji glede fitotoksične/fitopatogene občutljivosti;
the part of the treated crop or plant products where phytotoxic/phytopathogenic effects are observed;
dele tretiranih kultur ali rastlinskih proizvodov, na katerih se ugotovijo fitotoksični/fitopatogeni učinki;
adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality;
škodljivi učinek na količino in/ali kakovost pridelka tretirane kulture ali rastlinskih proizvodov;
adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment;
škodljivi učinek na življenjsko moč, kaljivost, brstenje, ukoreninjanje in začetek rasti tretiranih rastlin ali rastlinskih proizvodov, namenjenih za razmnoževanje;
where micro-organisms are disseminated, the adverse impact on adjacent crops.
škodljivi učinek na sosednje kulture pri razširjanju mikroorganizmov.
Where the label of the plant protection product includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, Member States shall make the evaluations referred to in points 2.4.3 to 2.4.5 in relation to the information supplied for the tank mix.
Kadar se na oznaki fitofarmacevtskega sredstva zahteva uporaba fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi in/ali dodatki v mešanici v tanku škropilnice, države članice izdelajo oceno iz točk od 2.4.3 do 2.4.5 v povezavi s predloženimi informacijami o mešanici v tanku škropilnice.
Where the label of the plant protection product label includes recommendations for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, Member States shall evaluate the appropriateness of the mix and of its conditions of use.
Kadar se na oznaki fitofarmacevtskega sredstva priporoča uporaba fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi in/ali dodatki v mešanici v tanku škropilnice, države članice ocenijo ustreznost mešanice in pogoje njene uporabe.
Where the available data indicate that the micro-organism or significant relevant metabolites/toxins, degradation and reaction products of the formulants persist in soils and/or in or on plant substances in significant quantities after use of the plant protection product in accordance with the proposed conditions of use, Member States shall evaluate the degree of adverse effects on subsequent crops.
Kadar razpoložljivi podatki kažejo, da se mikroorganizem ali pomembni relevantni metaboliti/toksini, razgradni in reakcijski produkti pomožnih snovi v formulaciji po uporabi fitofarmacevtskega sredstva pri predlaganih pogojih uporabe zadržujejo v tleh in/ali v ostankih rastlin ali na njih v znatnih količinah, države članice ocenijo stopnjo škodljivih učinkov na naslednje kulture.
Where the proposed use of a plant protection product is intended to have an effect on vertebrates, Member States shall evaluate the mechanism by which this effect is obtained and the observed effects on the behaviour and health of the target animals.
Kadar je predlagana uporaba fitofarmacevtskega sredstva namenjena za zatiranje vretenčarjev, države članice ocenijo mehanizem njegovega delovanja ter učinke na vedenje in zdravje ciljnih živali.
When the intended effect is to kill the target animal they shall evaluate the time necessary to obtain the death of the animal and the conditions under which death occurs.
Če je fitofarmacevtsko sredstvo namenjeno za uničevanje ciljnih živali, države članice ocenijo čas, potreben za pogin živali, in pogoje, pri katerih nastopi smrt.
all relevant information as provided for in part B of the annex to Regulation (EU) No 545/2011 and the results of the evaluation thereof, including the toxicological studies;
vse relevantne informacije iz dela B Priloge k Uredbi (EU) št. 545/2011 in rezultate njihove ocene, vključno s toksikološkimi študijami;
all relevant information on the plant protection product as provided for in part B of the Annex to Regulation (EU) No 545/2011, including toxicological studies and efficacy data.
vse relevantne informacije o fitofarmacevtskem sredstvu iz dela B Priloge k Uredbi (EU) št. 545/2011, vključno s toksikološkimi študijami in podatki o učinkovitosti.
Member States shall evaluate the analytical methods proposed for post-registration control and monitoring purposes of the viable and non-viable components both in the formulation and as residues in or on treated crops.
Države članice ocenijo predlagane analitske metode za nadzor in spremljanje po registraciji aktivnih in neaktivnih sestavin v formulaciji in njihovih ostankov v tretiranih kulturah in na njih.
Member States shall evaluate the analytical methods proposed to identify and quantify the toxicologically, ecotoxicologically or environmentally significant non-viable components resulting from the micro-organism and/or present as impurity or co-formulant (including eventually resulting breakdown and/or reaction products thereof).
Države članice ocenijo predlagane analitske metode za določanje in količinsko določanje toksikoloških, ekotoksikoloških ali okoljsko pomembnih neaktivnih sestavin, ki so posledica mikroorganizma in/ali so prisotne kot nečistoča ali pomožna snov v formulaciji (vključno z njihovimi morebitnimi razgradnimi in/ali reakcijskimi produkti).
This evaluation shall take into consideration the information on analytical methods provided for in part B of the Annex to Regulation (EU) No 544/2011 and in part B of the Annex to Regulation (EU) No 545/2011 and the results of the evaluation thereof.
Pri tej oceni se upoštevajo informacije o analitskih metodah iz dela B Priloge k Uredbi (EU) št. 544/2011 [Urad za publikacije vstavi številko – o izvajanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta glede zahtevanih podatkov za aktivne snovi] in dela B Priloge k Uredbi (EU) št. 545/2011 [Urad za publikacije vstavi številko – o izvajanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta glede zahtevanih podatkov za fitofarmacevtska sredstva] in rezultati njihove ocene.
the specificity and linearity of the proposed methods;
specifičnost in linearnost predlaganih metod;
the precision (repeatability) of the proposed methods;
natančnost (ponovljivost) predlaganih metod;
the importance of interferences;
pomembnost interferenc;
the accuracy of the proposed methods at appropriate concentrations;
točnost predlaganih metod pri ustreznih koncentracijah;
Member States shall evaluate the methods proposed to quantify and identify the specific strain concerned and especially methods that discriminate that strain from closely related strains.
Države članice ocenijo predlagane metode za količinsko določanje in identifikacijo zadevnega določenega seva in zlasti metode, ki ta sev razlikujejo od sorodnih sevov.
the specificity of the proposed methods;
specifičnost predlaganih metod;
the reproducibility (independent laboratory validation) of the proposed methods;
ponovljivost (neodvisna laboratorijska validacija) predlaganih metod;
Member States shall evaluate the methods proposed to identify the specific strain concerned and especially methods that discriminate that strain from closely related strains.
Države članice ocenijo predlagane metode za identifikacijo zadevnega določenega seva in zlasti metode, ki ta sev razlikujejo od sorodnih sevov.
due to the ability of micro-organisms to replicate, there is a clear difference between chemicals and micro-organisms used as plant protection products.
zaradi zmožnosti mikroorganizmov, da se razmnožujejo, je jasna razlika med kemikalijami in mikroorganizmi, ki se uporabljajo kot fitofarmacevtska sredstva.
Hazards arising are not necessarily of the same nature as those presented by chemicals, especially in relation to the capacity of micro-organisms to persist and multiply in different environments;
Nevarnosti zaradi tega niso nujno iste vrste kot nevarnosti pri kemikalijah, zlasti glede na zmožnosti mikroorganizmov, da obstanejo in se množijo v različnih okoljih;
the pathogenicity of the micro-organism to humans and non-target animals, the infectiveness of the micro-organism, the ability of the micro-organism to colonise, the toxicity of metabolites/toxins as well as the toxicity of the residual growth medium, contaminants and co-formulants, are important endpoints in assessing adverse effects arising from the plant protection product;
patogenost mikroorganizma za ljudi in neciljne živali, kužnost mikroorganizma, zmožnost mikroorganizma za kolonizacijo, toksičnost metabolitov/toksinov in toksičnost ostankov rastnega gojišča, kontaminantov in pomožnih snovi v formulaciji so pomembni parametri pri ocenjevanju škodljivih učinkov zaradi fitofarmacevtskega sredstva;
colonisation, infectiveness and toxicity comprise a complex set of interactions between micro-organisms and hosts and these endpoints may not be resolved easily as independent endpoints;
kolonizacija, kužnost in toksičnost zajemajo zapleten sklop interakcij med mikroorganizmi in gostitelji, teh parametrov pa ni lahko razločevati kot neodvisne parametre;
ability to persist and multiply in a host (indicative of colonisation or infectivity),
zmožnost obstoja in množenja v gostitelju (znak kolonizacije ali kužnosti),
ability to produce non-adverse or adverse effects in a host, indicative of infectivity, pathogenicity, and/or toxicity;
zmožnost povzročanja neškodljivih ali škodljivih učinkov v gostitelju (kar kaže na kužnost, patogenost in/ali toksičnost);
moreover, the complexity of the biological issues shall be taken into account in evaluating the hazards and risks presented by use of these plant protection products for human and animals.
pri oceni nevarnosti in tveganja za ljudi in živali pri uporabi teh fitofarmacevtskih sredstev je treba upoštevati zahtevnost bioloških vprašanj.
An assessment of pathogenicity and infectiveness is necessary even if the potential of exposure is deemed low;
Ocena patogenosti in kužnosti je potrebna, čeprav se šteje, da je možnost izpostavljenosti zelo majhna;
for risk assessment purposes the acute toxicity studies used shall, where available, include at least two doses (e.g. one very high dose and one corresponding to the expected exposure under practical conditions).
za oceno tveganja morajo uporabljene študije o akutni toksičnosti, kadar je to mogoče, vključevati vsaj dva odmerka (npr. en zelo velik odmerek in enega, ki ustreza pričakovani izpostavljenosti v dejanskih razmerah).
Member States shall evaluate operator exposure to the micro-organism, and/or to toxicologically relevant compounds in the plant protection product (e.g. their metabolites/toxins, residual growth medium, contaminants and co-formulants), likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions).
Države članice ocenijo izpostavljenost izvajalca tretiranja mikroorganizmu in/ali toksikološko relevantnim spojinam fitofarmacevtskega sredstva (npr. njihovim metabolitom/toksinom, ostankom rastnega gojišča, kontaminantom in pomožnim snovem v formulaciji), ki je verjetna pri predlaganih pogojih uporabe (ki vključujejo zlasti odmerek, način nanašanja in podnebne razmere).
When available, a European harmonised generic exposure database for plant protection products shall be used.
Kadar je na voljo, se uporabi usklajena evropska zbirka podatkov generične izpostavljenosti za fitofarmacevtska sredstva.
the medical data and the toxicity, infectivity and pathogenicity studies as 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.
Tier 1 tests shall permit an evaluation to be made of a micro-organism with respect to its ability to persist or grow in the host and its ability to cause effects/reactions in the host.
Testi na stopnji 1 omogočajo oceno mikroorganizma glede na njegovo zmožnost obstoja ali rasti v gostitelju ter zmožnost, da učinkuje/povzroči reakcije v gostitelju.
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 fast and complete clearance from the body, no activation of the immune system, no histopathological changes, and for replication temperatures far below or far above 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, glede temperatur za razmnoževanje pa so precej pod telesno temperaturo sesalcev ali nad njo.
These parameters can in some cases be assessed using acute studies and existing human data, and sometimes can only be assessed using repeated dose studies.
Ti parametri se v nekaterih primerih lahko ocenijo z uporabo akutnih študij in obstoječih podatkih za ljudi, včasih pa se lahko ocenijo samo z uporabo študij o ponovljenih odmerkih.
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 vplivov zaradi poklicne izpostavljenosti ob upoštevanju intenzivnosti in trajanja izpostavljenosti, vključno z izpostavljenostjo zaradi ponovljene uporabe med praktično uporabo.
The toxicity of certain metabolites/toxins can only be assessed, if it has been demonstrated that the test animals are actually exposed to these metabolites/toxins;
Toksičnost nekaterih metabolitov/toksinov se lahko oceni samo, če je bilo dokazano, da so jim bile testne živali dejansko izpostavljene;
other relevant information on the micro-organism, the metabolites/toxins, residual growth medium, contaminants and co-formulants in the plant protection product, such as their biological, physical and chemical properties (e.g. survival of the micro-organism at the body temperature of humans and animals, ecological niche, behaviour of the micro-organism and/or metabolites/toxins during application);
druge relevantne informacije o mikroorganizmu, metabolitih/toksinih, ostankih rastnega gojišča, kontaminantih in pomožnih snoveh v formulaciji v fitofarmacevtskem sredstvu, kot so njihove biološke, fizikalne in kemijske lastnosti (npr. preživetje mikroorganizma pri telesni temperaturi ljudi in živali; ekološka niša; obnašanje mikroorganizma in/ali metabolitov/toksinov med nanašanjem);
the toxicological studies provided for in part B of the Annex to Regulation (EU) No 545/2011;
toksikološke študije iz dela B Priloge k Uredbi (EU) št. 545/2011;
other relevant information provided for in part B of the Annex to Regulation (EU) No 545/2011 such as:
druge relevantne informacije iz dela B Priloge k Uredbi (EU) št. 545/2011, kot so:
field of use and nature of the crop or target,
področje uporabe in narava kulture ali cilja,
method of application including handling, loading and mixing of the plant protection product,
način nanašanja, vključno z ravnanjem s fitofarmacevtskim sredstvom ter polnjenjem in mešanjem fitofarmacevtskega sredstva,
On the basis of the information refereed to in (a) the following overall end-points should be established for single or repeated operator exposure following the intended use:
Na podlagi informacij iz odstavka (a) je treba ugotoviti skupne parametre za enkratno ali večkratno izpostavljenost izvajalca tretiranja glede na predvideno uporabo:
persistence or growth of the micro-organism in the host,
obstojnost ali rast mikroorganizma v gostitelju,
observed or expected effects of contaminants (including contaminating micro-organisms),
opaženi ali pričakovani učinki kontaminantov (vključno s kontaminatnimi mikroorganizmi),
observed or expected effects of relevant metabolites/toxins.
opaženi ali pričakovani učinki relevantnih metabolitov/toksinov.
If there are indications of colonisation in the host and/or if any adverse effects, indicative of toxicity/infectivity are observed, taking into account the exposure scenario (i.e. acute or repeated exposure), further testing is indicated.
Če se ob upoštevanju predvidenega poteka izpostavljenosti (tj. akutne ali večkratne) opazijo znaki kolonizacije v gostitelju in/ali kakršni koli škodljivi učinki, ki kažejo na toksičnost/kužnost, so potrebni dodatni testi.
This evaluation shall be made for each type of application method and application equipment proposed for use of the plant protection product as well as for the different types and sizes of containers to be used, taking into account mixing, loading operations, application of the plant protection product and cleaning and routine maintenance of application equipment.
Ta ocena se izdela za vsak predlagani način nanašanja in predlagano vrsto opreme za nanašanje fitofarmacevtskega sredstva, pa tudi za različne vrste in velikost rezervoarjev, ki se bodo uporabljali, pri čemer se upoštevajo postopki mešanja, polnjenja rezervoarja, nanašanja sredstva in čiščenja ter rednega vzdrževanja opreme za nanašanje.
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 may also be taken into account.
Kadar je relevantno, se lahko upoštevajo tudi druga registrirane uporabe fitofarmacevtskega sredstva na območju predvidene uporabe, ki vsebuje enako aktivno snov ali iz katere izvirajo enaki ostanki.
It shall be taken into account that if replication of the micro-organism is expected, exposure assessment could be highly speculative.
Če se pričakuje, da se bo mikroorganizem razmnoževal, se upošteva, da bi bila lahko zato ocena izpostavljenosti zelo špekulativna.
The absence or presence of the potential for colonisation or the possibility of effects in operators at the tested dose levels as provided for in part B of the Annex to Regulation (EU) No 544/2011 and in part B of the Annex to Regulation (EU) No 545/2011 shall be assessed with regard to measured or estimated levels of human exposure.
Zmožnost ali nezmožnost kolonizacije ali možnost učinkov na izvajalce tretiranja pri testiranih stopnjah odmerkov iz dela B Priloge k Uredbi (EU) št. 544/2011 in dela B Priloge k Uredbi (EU) št. 545/2011 se ocenijo ob upoštevanju izmerjenih ali ocenjenih stopenj človekove izpostavljenosti.
This risk assessment, preferably quantitative, shall include consideration of e.g. mode of action, biological, physical and chemical properties of the micro-organism and other substances in the formulation.
Ocena tveganja, po možnosti količinska, upošteva npr. način delovanja, biološke, fizikalne in kemijske lastnosti mikroorganizma ter druge snovi v formulaciji.
the type of packaging;
vrsti embalaže;
its dimensions and capacity;
njeni velikosti in prostornini;
the size of the opening;
velikosti odprtine;
the type of closure;
vrsti zapiranja;
its strength, leakproofness and resistance to normal transport and handling;
njeni trdnosti, tesnjenju in odpornosti pri običajnem transportu in ravnanju;
obtainability and suitability;
dostopnosti in primernosti;
effectiveness;
učinkovitosti;
ease of wearing taking into account physical stress and climatic conditions;
lahkem nošenju, pri čemer se upoštevajo fizični napor in podnebne razmere;
resistance to and compatibility with the plant protection product.
njeni odpornosti proti fitofarmacevtskemu sredstvu in združljivosti z njim.