natgillin/translations-raw huggingface dataset:
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 določeno korist v okoliščinah kmetijske pridelave, zdravja rastlin in okolja (vključno s podnebnimi razmerami), ki so verjetni v praksi na območju predlagane uporabe.
Member States shall evaluate the degree of adverse effects on the treated crop after use of the plant protection product according to the proposed conditions of use in comparison, where relevant, with a suitable reference product or products, where they exist, and/or an untreated control.
Države članice ocenijo stopnjo škodljivih učinkov na tretirano kulturo po uporabi fitofarmacevtskega sredstva v skladu s predlaganimi pogoji uporabe v primerjavi, kadar je ustrezno, z ustreznim referenčnim sredstvom ali sredstvi, kadar ti obstajajo, in/ali kontrolo netretiranih rastlin.
This evaluation will take into consideration the following information:
Pri tem ocenjevanju bodo upoštevani naslednji podatki:
efficacy data;
podatki o učinkovitosti;
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 ustrezni podatki o fitofarmacevtskem sredstvu, kakršni so vrsta fitofarmacevtskega sredstva, odmerek, način nanašanja, pogostnost 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 ustrezne informacije o mikroorganizmu, vključno z biološkimi lastnostmi, tj. načinom delovanja, preživetjem, specifičnostjo gostitelja.
This evaluation will include:
Ta ocena bo zajemala:
the nature, frequency, level and duration of observed phytotoxic/phytopathogenic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them;
vrsto, pogostnost, stopnjo in trajanje ugotovljenih fitotoksičnih/fitopatogenskih učinkov ter okoliščine kmetijske pridelave, zdravja 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 sortami gojenih rastlin v smislu njihove občutljivosti za fitotoksične/fitopatogenske učinke;
the part of the treated crop or plant products where phytotoxic/phytopathogenic effects are observed;
dele tretiranih rastlin ali rastlinskih proizvodov, na katerih se ugotovijo fitotoksični/fitopatogenski učinki;
adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality;
škodljivi vpliv na količino in/ali kakovost pridelka tretiranih rastlin 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 vpliv na tretirane rastline ali rastlinske proizvode, ki se bodo uporabljali za razmnoževanje v smislu aktivnosti, kaljivosti, brstenja, ukoreninjanja in začetka rasti;
where micro-organisms are disseminated, the adverse impact on adjacent crops.
škodljivi vpliv na sosednje posevke, kadar se mikroorganizmi razširjajo.
Where the plant protection product label 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 oznaka fitofarmacevtskega sredstva vsebuje zahteve za uporabo fitofarmacevtskega sredstva kot mešanice z drugimi fitofarmacevtskimi sredstvi in/ali dodatki, države članice oblikujejo oceno iz točk od 2.4.3 do 2.4.5 v povezavi s predloženimi informacijami o mešanici.
Where 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 oznaka fitofarmacevtskega sredstva vsebuje priporočila za uporabo fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi in/ali dodatki v mešanici, države članice ocenijo ustreznost mešanice in pogoje 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 according to 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 ustrezni metaboliti/toksini, razgradni in reakcijski produkti pomožnih snovi iz formulacije po uporabi fitofarmacevtskega sredstva v predlaganih pogojih uporabe zadržujejo v tleh in/ali v rastlinah ali na njih v znatnih količinah, države članice ocenijo stopnjo škodljivih vplivov na poznejše 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 učinkovanje na vretenčarje, države članice ocenijo mehanizem, s katerim se ta učinek doseže, in opaženi vpliv na obnašanje 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.
Kadar je predvideno, da učinek fitofarmacevtskega sredstva uniči ciljno žival, države članice ocenijo čas, potreben za pogin živali, in pogoje, pri katerih nastopi smrt.
This evaluation will take into consideration the following information:(a) all relevant information as provided for in Annex IIB and the results of the evaluation thereof, including the toxicological studies;
Pri tej oceni se bodo upoštevale naslednje informacije:(a) vse ustrezne informacije, kakor je določeno v Prilogi IIB, in rezultati ocene teh informacij, skupaj s toksikološkimi študijami;
all relevant information on the plant protection product as provided for in Annex IIIB, including toxicological studies and efficacy data.
vse ustrezne informacije o fitofarmacevtskem sredstvu, kakor je določeno v Prilogi IIIB, skupaj 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 kontrolo in spremljanje po registraciji aktivnih in neaktivnih sestavin v formulaciji in njihovih ostankov v in na tretiranih kulturah.
Sufficient validation is required for pre-authorisation methods and post-authorisation monitoring methods.
Metode pred registracijo in metode spremljanja po registraciji je treba ustrezno validirati.
Methods that are considered suitable for post-authorisation monitoring must be clearly identified.
Natančno je treba določiti metode, ki se štejejo kot ustrezne za spremljanje po registraciji.
Non-viable components
Neaktivne sestavine
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 navzoče kot nečistota ali pomožna snov v formulaciji (vključno z njihovimi morebitnimi razgradnimi in/ali reakcijskimi produkti).
This evaluation will take into consideration the information on analytical methods provided for in Annex IIB and IIIB and the results of the evaluation thereof.
Pri tej oceni se bodo upoštevale informacije o analitskih metodah, določenih v prilogah IIB in IIIB, in rezultati ocene teh metod.
In particular, the following information must be taken into account:(a) the specificity and linearity of the proposed methods,
Upoštevati je treba zlasti naslednje informacije:(a) 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;
the limit of quantification of the proposed methods.
meja določanja delovnega območja predlaganih metod.
Viable components
Aktivne sestavine
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 soja in zlasti metode, ki ta soj razlikujejo od sorodnih sojev.
In particular, the following information must be taken into account:(a) the specificity of the proposed methods,
Upoštevati je treba zlasti naslednje informacije:(a) specifičnost predlaganih metod;
the quantifiability of the proposed methods.
količinska merljivost predlaganih metod.
Non-viable residues
Neaktivni ostanki
Member States shall evaluate the analytical methods proposed to identify and quantify the toxicologically, ecotoxicologically or environmentally significant non-viable residues resulting from the micro-organism (including eventually resulting breakdown and/or reaction products thereof).
Države članice ocenijo predlagane analitske metode za identifikacijo in količinsko določanje toksikoloških, ekotoksikoloških ali okoljsko pomembnih neaktivnih ostankov, ki so posledica mikroorganizma (vključno z njihovimi morebitnimi razgradnimi in/ali reakcijskimi produkti).
In particular, the following information must be taken into account:
Upoštevati je treba zlasti naslednje informacije:
the specificity and linearity of the proposed methods,
specifičnost in linearnost predlaganih metod;
the reproducibility (independent laboratory validation) of the proposed methods,
obnovljivost (neodvisna laboratorijska validacija) predlaganih metod;
Viable residues
Aktivni ostanki
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 soja in zlasti metode, ki ta soj razlikujejo od sorodnih sojev.
the specificity of the proposed methods,
specifičnost predlaganih metod;
Impact on human or animal health
Vpliv na zdravje ljudi ali živali
The impact on human or animal health must be evaluated.
Oceniti je treba vpliv na zdravje ljudi ali živali.
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 sposobnosti 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, ki iz tega izvirajo, niso nujno iste vrste kakor nevarnosti, ki jih predstavljajo kemikalije, zlasti glede na sposobnost mikroorganizmov, da so obstojni in se množijo v različnem okolju;
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, infektivnost mikroorganizma, sposobnost mikroorganizma za kolonizacijo, toksičnost metabolitov/toksinov in toksičnost ostankov rastnega gojišča, onesnaževalcev in pomožnih snovi v formulaciji so pomembni parametri pri ocenjevanju škodljivih učinkov, ki izhajajo iz 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, infektivnost in toksičnost obsegajo zapleten sklop interakcij med mikroorganizmi in gostitelji, teh parametrov pa ni lahko razločevati kot neodvisne parametre;
in combining these endpoints, the most important aspects of the micro-organism that must be assessed are:
pri kombiniranju teh parametrov so najpomembnejši vidiki mikroorganizma, ki jih je treba oceniti, naslednji:
ability to persist and multiply in a host (indicative of colonisation or infectivity),
sposobnost za obstoj in množenje v gostitelju (znak kolonizacije ali infektivnosti),
ability to produce non-adverse or adverse effects in a host, indicative of infectivity, pathogenicity, and/or toxicity;
sposobnost za povzročitev (neškodljivih ali škodljivih) učinkov v gostitelju (kar kaže na infektivnost, patogenost in/ali toksičnost);
moreover, the complexity of the biological issues should 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, ki ju uporaba teh fitofarmacevtskih sredstev predstavlja pri ljudeh in živalih, 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 infektivnosti je potrebna, četudi se šteje, da je možnost za izpostavljenost zelo majhna;
for risk assessment purposes the acute toxicity studies used should, where available, include at least two doses (e.g. one very high dose and one corresponding to the expected exposure under practical conditions).
za namene ocene tveganja morajo uporabljene študije o akutni toksičnosti, kadar je to mogoče, vključevati vsaj dva odmerka (npr. en zelo visok 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 uporabnika mikroorganizmu in/ali toksikološko pomembnim sestavinam fitofarmacevtskega sredstva (npr. njihovim metabolitom/toksinom, ostankom rastnega gojišča, onesnaževalcem in pomožnim snovem v formulaciji), ki je verjetna pri predlaganih pogojih uporabe (ki vključujejo zlasti odmerek, način nanašanja in podnebne razmere).
Realistic data on exposure levels must be used and, if such data are not available, a suitable, validated calculation model.
Uporabiti je treba dejanske podatke o stopnjah izpostavljenosti, če taki podatki niso na voljo, pa se uporabi ustrezen validirani matematični model.
When available, a European harmonised generic exposure database for plant protection products should 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 Annex IIB, and the results of the evaluation thereof.
zdravstveni podatki in študije o toksičnosti, infektivnosti in patogenosti, kakor je določeno v Prilogi IIB, ter rezultati ocene teh študij.
Tier 1 tests should 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.
Preskusi na stopnji 1 morajo omogočati oceno mikroorganizma glede na njegovo sposobnost za obstoj ali rast v gostitelju ter sposobnosti, 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 nesposobnost obstoja in množenja v gostitelju ter na nesposobnost povzročitve neškodljivih ali škodljivih učinkov v gostitelju, vključujejo hitro in popolno izginotje iz telesa, neaktiviranje imunskega sistema, nenavzočnost histopatoloških sprememb, kar zadeva temperature za razmnoževanje, pa so precej pod ali nad telesno temperaturo sesalcev.
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 po akutnih študijah in obstoječih podatkih za ljudi, včasih pa se lahko ocenijo samo po študijah o ponovljenih odmerkih.
Evaluation based on relevant parameters of Tier 1 tests should 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 osnovi ustreznih parametrov preskusov na stopnji 1 naj bi vodila do ocene možnih vplivov zaradi poklicne izpostavljenosti ob upoštevanju intenzivnosti in trajanja izpostavljenosti, vključno z izpostavljenostjo zaradi ponovljene uporabe med dejansko 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 preskusne 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 pomembne informacije o mikroorganizmu, metabolitih/toksinih, ostankih rastnega gojišča, onesnaževalcih in pomožnih snoveh v formulaciji v fitofarmacevtskem sredstvu, kakršne 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 Annex IIIB;
toksikološke študije iz Priloge IIIB;
other relevant information provided for in Annex IIIB such as:
druge pomembne informacije, določene v Prilogi IIIB, kakršne so:
composition of the preparation,
sestava pripravka,
nature of the preparation,
vrsta pripravka,
size, design and type of packaging,
velikost, zasnova in vrsta embalaže,
field of use and nature of the crop or target,
področje uporabe in vrsta kulture ali cilja,
method of application including handling, loading and mixing of the plant protection product,
način nanašanja, vključno z ravnanjem, polnjenjem in mešanjem fitofarmacevtskega sredstva,
exposure reduction measures recommended,
priporočeni ukrepi za zmanjšanje izpostavljenosti,
protective clothing recommendations,
priporočena zaščitna obleka in oprema,
maximum application rate,
največji uporabljeni odmerek,
minimum spray application volume stated on the label,
najmanjša količina nanašanja škropiva, navedena na oznaki,
number and timing of applications.
število in časovni razpored nanašanja.
On the basis of the information mentioned in (a) the following overall end-points should be established for single or repeated operator exposure following the intended use:
Na podlagi informacij iz (a) je treba ugotoviti skupne parametre za enkratno ali večkratno izpostavljenost uporabnika glede na predvideno uporabo:
persistence or growth of the micro-organism in the host,
obstoj ali rast mikroorganizma v gostitelju,
adverse effects observed,
opaženi škodljivi učinki,
observed or expected effects of contaminants (including contaminating micro-organisms),
opaženi ali pričakovani učinki onesnaževalcev (vključno s kontaminatnimi mikroorganizmi),
observed or expected effects of relevant metabolites/toxins.
opaženi ali pričakovani učinki pomembnih 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/infektivnost, so potrebni dodatni preskusi.
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 vsako predlagano metodo nanašanja in predlagano vrsto naprav 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 naprav 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 ustrezno, se lahko upošteva tudi druga dovoljena uporaba fitofarmacevtskega sredstva na območju predvidene uporabe, ki vsebuje enako aktivno snov ali iz katere izvirajo enaki ostanki.
It should be taken into account that if replication of the micro-organism is expected, exposure assessment could be highly speculative.
Če se pričakuje razmnoževanje mikroorganizma, je treba upoštevati, 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 Annex IIB and IIIB should be assessed with regard to measured or estimated levels of human exposure.
Možnost ali nezmožnost za kolonizacijo ali možnost učinkov na uporabnike pri preskušenih stopnjah odmerkov, kakor je določeno v prilogah IIB in IIIB, je treba oceniti ob upoštevanju izmerjenih ali ocenjenih stopenj človekove izpostavljenosti.
This risk assessment, preferably quantitative, should 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, mora upoštevati npr. način delovanja, biološke, fizikalne in kemijske lastnosti mikroorganizma ter drugih snovi v formulaciji.