natgillin/translations-raw huggingface dataset:
In interpreting the results of evaluations, Member States shall take into consideration possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of under-estimating their importance are reduced to a minimum.
Države članice pri razlagi rezultatov ocenjevanja upoštevajo možne elemente nezanesljivosti podatkov, pridobljenih med ocenjevanjem, da zagotovijo, da je možnost neodkritja škodljivih učinkov ali podcenjevanja njihove pomembnosti čim manj škodljiv.
The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk.
Postopek odločanja se preuči zaradi ugotavljanja kritičnih točk odločanja ali posameznih podatkov, katerih nezanesljivost bi lahko povzročila napačno razvrstitev tveganja.
The first evaluation made shall be based on the best available data or estimates reflecting the realistic conditions of use of the plant protection product.
Prvo ocenjevanje se izvede na podlagi najprimernejših razpoložljivih podatkov ali ocen, ki odražajo dejanske razmere uporabe fitofarmacevtskega sredstva.
This should be followed by a repeat evaluation, taking account of potential uncertainties in the critical data and of a range of use conditions that are likely to occur and resulting in a realistic worst-case approach, to determine whether it is possible that the initial evaluation could have been significantly different.
Temu sledi ponovno ocenjevanje, ki upošteva morebitno nezanesljivost pri kritičnih podatkih in obseg verjetnih razmer uporabe za realistični pristop za najhujši možni primer ter s katerim se določi možnost bistvenega odstopanja od prve ocene.
Where specific principles of Section 2 provide for the use of calculation models in the evaluation of a plant protection product, those models shall:
Kadar posebna načela iz oddelka 2 pri oceni fitofarmacevtskega sredstva določajo uporabo matematičnih modelov, ti modeli:
make a best possible estimation of all relevant processes involved taking into account realistic parameters and assumptions,
zagotavljajo najboljšo možno oceno vseh relevantnih postopkov, pri čemer se upoštevajo dejanski parametri in predpostavke,
be submitted to an analysis as referred to in B, point 1.4,
se predložijo v analizo iz točke 1.4 dela B,
be reliably validated with measurements carried out under circumstances relevant for the use of the model,
se zanesljivo validirajo z meritvami v okoliščinah, relevantnih za uporabo modela,
be relevant to the conditions in the area of use.
so relevantni za razmere na območju uporabe.
Where metabolites, degradation or reaction products are referred to in the specific principles, only those that are relevant for the proposed criterion shall be taken into consideration.
Kadar se posebna načela sklicujejo na metabolite, razgradne ali reakcijske produkte, se upoštevajo samo tisti, ki so povezani s predlaganim merilom.
Member States shall, for the evaluation of the data and information submitted in support of applications, and without prejudice to the general principles of Section 1, implement the following principles.
Države članice pri ocenjevanju podatkov in informacij, predloženih v podporo vlogi, ter brez poseganja v splošna načela iz oddelka 1, izvajajo naslednja načela.
Where the proposed use concerns the control of or protection against an organism, Member States shall evaluate the possibility that this organism could be harmful under the agricultural, plant health and environmental (including climatic) conditions in the area of the proposed use.
Kadar gre pri predlagani uporabi za nadzor ali varovanje pred nekim organizmom, države članice ocenijo možnost, da bi bil ta organizem lahko škodljiv v razmerah kmetijske pridelave, zdravstvenega varstva rastlin ali okolja (vključno s podnebnimi razmerami) na območju predlagane uporabe.
Where the proposed use concerns an effect other than the control of or protection against an organism, Member States shall evaluate whether significant damage, loss or inconvenience could occur under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use if the plant protection product were not used.
Kadar gre pri predlagani uporaba za učinek, ki ni nadzor ali varovanje pred nekim organizmom, države članice ocenijo, ali bi na območju predlagane uporabe lahko nastala znatna škoda, izguba ali težava v razmerah kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami), če se fitofarmacevtsko sredstvo ne uporabi.
Member States shall evaluate the efficacy data on the plant protection product as provided for in the Annex to Regulation (EU) No 545/2011 having regard to the degree of control or the extent of the effect desired and having regard to the relevant experimental conditions such as:
Države članice ocenijo zahtevane podatke o učinkovitosti fitofarmacevtskega sredstva iz Priloge k Uredbi Komisije (EU) št. 545/2011 ob upoštevanju stopnje nadzora ali obsega želenega učinka ter relevantnih eksperimentalnih razmer, kot so:
the choice of the crop or cultivar,
izbira kulture ali kultivarja,
the agricultural and environmental (including climatic) conditions,
razmere kmetijske pridelave in okoljske razmere (vključno s podnebnimi razmerami),
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 plant protection product used,
količina uporabljenega 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.
Member States shall evaluate the performance of the plant protection product in a range of agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use and in particular:
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, in sicer zlasti:
the level, consistency and duration of the effect sought in relation to the dose in comparison with a suitable reference product or products and an untreated control;
stopnjo, doslednost in trajanje želenega učinka glede na odmerek v primerjavi z ustreznim referenčnim sredstvom ali sredstvi in kontrolo netretiranih rastlin;
where relevant, 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 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 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 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) na področju predlagane uporabe.
Where the 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 2.1.1 to 2.1.4 in relation to the information supplied for the tank mix.
Kadar se na oznaki sredstva zahteva uporaba fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi in/ali dodatki v mešanici v tanku škropilnice, države članice izdelajo ocene iz točk 2.1.1 do 2.1.4 v povezavi s predloženimi informacijami o mešanici v tanku škropilnice.
Where the 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 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.
Member States shall evaluate the degree of adverse effects on the treated crop after use of the plant protection product in accordance with 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 pod predlaganimi pogoji uporabe v primerjavi, kadar je to relevantno, z ustreznim referenčnim sredstvom ali sredstvi, če obstajajo, in/ali kontrolo netretiranih rastlin.
This evaluation shall take into consideration the following information:
Pri tej oceni se upoštevajo naslednje informacije:
the efficacy data provided for in the Annex to Regulation (EU) No 545/2011;
podatki o učinkovitosti iz Priloge k Uredbi (EU) št. 545/2011;
other relevant information on the plant protection product such as nature of the preparation, dose, method of application, number and timing of applications;
drugi relevantni podatki o fitofarmacevtskem sredstvu, kot so narava pripravka, odmerek, način nanašanja, pogostost in časovni razpored nanašanja;
all relevant information on the active substance as provided for in of the Annex to Regulation (EU) No 544/2011, including mode of action, vapour pressure, volatility and water solubility.
vse relevantne informacije o aktivni snovi iz Priloge k Uredbi (EU) št. 544/2011, vključno z načinom delovanja, parnim tlakom, hlapnostjo in topnostjo v vodi;
This evaluation shall include:
Ta ocena vključuje:
the nature, frequency, level and duration of observed phytotoxic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them;
naravo, pogostost, stopnjo in trajanje ugotovljenih fitotoksičnih učinkov ter razmere kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami), ki vplivajo nanje;
the differences between main cultivars with regard to their sensitivity to phytotoxic effects;
razlike v fitotoksični občutljivosti med glavnimi kultivarji gojenih rastlin;
the part of the treated crop or plant products where phytotoxic effects are observed;
dele tretirane kulture ali rastlinskih proizvodov, na katerih se ugotovijo fitotoksični učinki;
the 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;
the 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 volatile products are concerned, the adverse impact on adjacent crops.
škodljivi učinek na sosednje kulture pri lahko hlapnih fitofarmacevtskih sredstvih.
Where the available data indicate that the active substance or significant metabolites, degradation and reaction products 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 aktivna snov ali pomembni metaboliti, razgradni in reakcijski produkti 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.
This evaluation shall be carried out as specified in point 2.2.1.
Ta ocena se izdela v skladu s točko 2.2.1.
Where the product label includes requirements for use of the plant protection product with other plant protection products or with adjuvants as a tank mix, the evaluation as specified in point 2.1.1 shall be carried out in relation to the information supplied for the tank mix.
Kadar se na oznaki sredstva zahteva uporaba fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi in/ali dodatki v mešanici v tanku škropilnice, države članice izdelajo oceno iz točke 2.1.1 v povezavi s predloženimi informacijami o mešanici v tanku škropilnice.
Where the proposed use of the plant protection product aims 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; 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 predlagana uporaba fitofarmacevtskega sredstva namenjena za zatiranje vretenčarjev, države članice ocenijo mehanizem njegovega delovanja ter učinke na vedenje in zdravje ciljnih živali; 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 the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof, including the toxicological and metabolism studies;
vse relevantne informacije iz Priloge k Uredbi (EU) št. 544/2011 in rezultati njihove ocene, vključno s toksikološkimi študijami in študijami o presnovi;
all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 545/2011, including toxicological studies and efficacy data.
vse relevantne informacije o fitofarmacevtskem sredstvu iz Priloge k Uredbi (EU) št. 545/2011, vključno s toksikološkimi študijami in podatki o učinkovitosti.
Member States shall evaluate operator exposure to the active substance and/or to toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions) using by preference realistic data on exposure and, if such data are not available, a suitable, validated calculation model.
Države članice ocenijo izpostavljenost izvajalca tretiranja aktivni snovi in/ali toksikološko relevantnim sestavinam fitofarmacevtskega sredstva, do katere lahko pride pri predlaganih pogojih uporabe (vključno zlasti z odmerkom, načinom nanašanja in podnebnimi razmerami), pri čemer pri ocenjevanju po možnosti uporabljajo realistične podatke o izpostavljenosti, če pa takih podatkov ni, pa validiran matematični model.
the toxicological and metabolism studies as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof including the acceptable operator exposure level (AOEL).
toksikološke študije in študije o presnovi iz Priloge k Uredbi (EU) št. 544/2011 in rezultati njihove ocene, vključno s sprejemljivo ravnjo izpostavljenosti izvajalca tretiranja.
The acceptable operator exposure level is the maximum amount of active substance to which the operator may be exposed without any adverse health effects.
Sprejemljiva raven izpostavljenosti izvajalca tretiranja je največja količina aktivne snovi, ki ji je izvajalec tretiranja lahko izpostavljen brez škodljivih učinkov na zdravje.
The AOEL is expressed as milligrams of the chemical per kilogram body weight of the operator.
Sprejemljiva raven izpostavljenosti izvajalca tretiranja je izražena v miligramih kemikalije na kilogram telesne teže izvajalca tretiranja.
The AOEL is based on the highest level at which no adverse effect is observed in tests in the most sensitive relevant animal species or, if appropriate data are available, in humans;
Sprejemljiva raven izpostavljenosti izvajalca tretiranja temelji na najvišji ravni, pri kateri pri testih še ni zaznati nobenega škodljivega učinka na najbolj občutljive relevantne živalske vrste, ali če so na voljo ustrezni podatki, ljudi;
other relevant information on the active substances such as physical and chemical properties;
druge relevantne informacije o aktivnih snoveh, kot so fizikalne in kemijske lastnosti;
the toxicological studies provided for in the Annex to Regulation (EU) No 545/2011, including where appropriate dermal absorption studies;
toksikološke študije iz Priloge k Uredbi (EU) št. 545/2011, vključno s študijami o dermalni absorpciji, kadar so primerne;
other relevant information as provided for in the Annex to Regulation (EU) No 545/2011 such as:
druge relevantne informacije iz Priloge k Uredbi (EU) št. 545/2011, kot so:
nature of the preparation,
narava pripravka,
field of use and nature of crop or target,
področje uporabe in narava kulture ali ciljnega organizma,
method of application including handling, loading and mixing of product,
način nanašanja, vključno z ravnanjem, polnjenjem in mešanjem sredstva,
maximum application rate,
največji odmerek,
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 account of 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, kakor tudi za različne vrste in velikosti rezervoarjev, pri čemer se upoštevajo postopki mešanja, polnjenja rezervoarja, nanašanja in čiščenja ter rednega vzdrževanja opreme za nanašanje.
Member States shall examine information relating to the nature and characteristics of the packaging proposed with particular reference to the following aspects:
Države članice preučijo informacije o naravi in značilnostih predlagane embalaže s posebnim poudarkom na:
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,
its resistance to and compatibility with the contents.
njeni odpornosti proti vsebini in združljivosti z njo.
Member States shall examine the nature and characteristics of the protective clothing and equipment proposed with particular reference to the following aspects:
Države članice preučijo naravo in značilnosti predlagane zaščitne obleke in opreme s posebnim poudarkom na:
obtainability and suitability,
dostopnosti in primernosti,
ease of wearing taking into account physical stress and climatic conditions.
lahkem nošenju, pri čemer se upoštevajo fizični napor in podnebne razmere.
Member States shall evaluate the possibility of exposure of other humans (bystanders or workers exposed after the application of the plant protection product) or animals to the active substance 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 (drugih navzočih oseb ali delavcev, izpostavljenih po nanosu fitofarmacevtskega sredstva) ali živali aktivni snovi in/ali drugim toksikološko relevantnim sestavinam fitofarmacevtskih sredstev pri predlaganih pogojih uporabe.
the toxicological and metabolism studies on the active substance as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof, including the acceptable operator exposure level;
toksikološke študije in študije o presnovi aktivne snovi iz Priloge k Uredbi (EU) št. 544/2011 in rezultati njihove ocene, vključno s sprejemljivo ravnjo izpostavljenosti izvajalca tretiranja;
other relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 545/2011 such as:
druge relevantne informacije o fitofarmacevtskem sredstvu iz Priloge k Uredbi (EU) št. 545/2011, kot so:
re-entry periods, necessary waiting periods or other precautions to protect humans and animals,
karenca za ponovni dostop, potrebna varnostna karenca ali drugi varnostni ukrepi za zaščito ljudi in živali,
maximum spray application volume,
največja poraba škropiva pri nanašanju,
excess remaining on plants and plant products after treatment,
čezmerni ostanki na rastlinah in rastlinskih proizvodih po tretiranju,
Member States shall evaluate the specific information on toxicology as provided for in the Annex to Regulation (EU) No 544/2011 and in particular:
Države članice ocenijo posebne informacije o toksikologiji iz Priloge k Uredbi (EU) št. 544/2011, in zlasti:
the determination of an acceptable daily intake (ADI),
določitev sprejemljivega dnevnega vnosa,
the identification of metabolites, degradation and reaction products in treated plants or plant products,
opredelitev metabolitov, razgradnih in reakcijskih produktov v tretiranih rastlinah ali rastlinskih proizvodih,
behaviour of residues of the active substance and its metabolites from the time of application until harvest, or in the case of post-harvest uses, until outloading of stored plant products.
obnašanje ostankov aktivne snovi in njenih metabolitov od nanosa do spravila‚ ali pri uporabi po spravilu, do odpreme rastlinskih proizvodov iz skladišč.
Prior to evaluating the residue levels in the reported trials or in products of animal origin Member States shall examine the following information:
Pred oceno podatkov o količini ostankov fitofarmacevtskih ostankov iz izvedenih poskusov ali v živilih živalskega izvora morajo države članice preučiti naslednje podatke:
data on the proposed good agricultural practice, including data on application as provided for in the Annex to Regulation (EU) No 545/2011 and proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses,
podatke o predlagani dobri kmetijski praksi, vključno s podatki o nanašanju iz Priloge k Uredbi (EU) št. 545/2011, o predlagani karenci pred spravilom ali obdobju prepovedi uporabe ali obdobju shranjevanja pri uporabi po spravilu,
analytical methods and the residue definition.
analitske metode in opredelitev ostankov.
On the basis of suitable statistical models Member States shall evaluate the residue levels observed in the reported trials.
Na podlagi ustreznih statističnih modelov države članice ocenijo količine ostankov, ugotovljene v navedenih poskusih.
This evaluation shall be made for each proposed use and shall take into consideration:
Ta ocena se izdela za vsak predlagani način uporabe in upošteva:
the proposed conditions of use of the plant protection product;
predlagane pogoje uporabe fitofarmacevtskega sredstva;
the specific information on residues in or on treated plants, plant products, food and feed as provided for in the Annex to Regulation (EU) No 545/2011 and the distribution of residues between edible and non-edible parts;
posebne informacije o ostankih v tretiranih rastlinah, rastlinskih proizvodih, živilih in krmi ali na njih iz Priloge k Uredbi (EU) št. 545/2011 ter porazdelitev ostankov med užitnimi in neužitnimi deli;
the specific information on residues in or on treated plants, plant products, food and feed as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof;
posebne informacije o ostankih v tretiranih rastlinah, rastlinskih proizvodih, živilih in krmi ali na njih iz Priloge k Uredbi (EU) št. 544/2011 ter rezultate njihove ocene;