natgillin/translations-raw huggingface dataset:
Studies shall cover the realistic worst case situation, and the duration necessary for observation of potential leaching, taking into account the soil type, climatic conditions, the application rate and the frequency and period of application.
Študije zajemajo realno najslabše razmere in čas, ki je potreben za opazovanje možnega izpiranja, pri čemer se upoštevajo vrsta tal, podnebne razmere, odmerek ter pogostost in obdobje nanašanja.
Water percolating from soil columns shall be analysed at suitable intervals, while residues in plant material shall be determined at harvest.
Voda, ki pronica skozi kolone vzorcev tal, se analizira v primernih časovnih razmikih, ostanki v rastlinskem materialu pa se določijo ob spravilu.
Residues in the soil profile in at least five layers shall be determined on termination of experimental work.
Na koncu poskusnega dela se določijo ostanki v profilu tal v vsaj petih plasteh.
Intermediate sampling shall be avoided, since removal of plants (except for harvesting in accordance with normal agricultural practice) and soil influence the leaching process.
Vmesno vzorčenje se ne izvaja, ker odstranitev rastlin (razen pri spravilu v skladu z običajno kmetijsko prakso) in tal vpliva na postopek izpiranja.
Precipitation, soil and air temperatures shall be recorded at regular intervals, at least on a weekly base.
Padavine ter temperatura tal in zraka se evidentirajo v rednih časovnih razmikih vsaj enkrat na teden.
The depth of the lysimeters shall be at least 100 cm.
Lizimetri so globoki vsaj 100 cm.
The soil cores shall be undisturbed.
Vzorci profilov tal so neporušeni.
Soil temperatures shall be similar to those pertaining in the field.
Temperature vzorcev tal so podobne temperaturam na terenu.
Where necessary, supplementary irrigation shall be provided to ensure optimal plant growth and to ensure that the quantity of percolation water is similar to that in the regions for which authorisation is sought.
Po potrebi se zagotovi dodatno namakanje, ki omogoča optimalno rast rastlin in zagotavlja, da je količina vode, ki pronica, podobna količini vode na območjih, za katera se zahteva registracija.
When during the study the soil has to be disturbed for agricultural reasons it shall not be disturbed deeper than 25 cm.
Globina obdelave tal med potekom študije ne presega 25 cm.
Field leaching studies shall be performed, where necessary, to provide information on:
Terenske študije o izpiranju se po potrebi izvedejo za zagotovitev informacij o:
The decision whether field leaching studies are to be carried out, as an experimental outdoor study in the framework of a tiered leaching assessment scheme shall take into account the results of degradation and other mobility studies and the predicted environmental concentrations in groundwater (PECGW), calculated in accordance with the provisions of Section 9 of Part A of the Annex to Regulation (EU) No 284/2013.
Pri odločanju o izvedbi terenskih študij o izpiranju, pri čemer se izvedejo kot eksperimentalne študije na prostem v okviru večstopenjskega sistema ocenjevanja izpiranja, se upoštevajo rezultati študij o razgradnji in drugih študij o mobilnosti ter predvidene okoljske koncentracije v podtalnici (PECGW), izračunane v skladu z določbami oddelka 9 dela A Priloge k Uredbi (EU) št. 284/2013.
Studies shall cover the realistic worst case situation, taking into account the soil type, climatic conditions, the application rate and the frequency and period of application.
Študije zajemajo realno najslabše razmere, pri čemer se upoštevajo vrsta tal, podnebne razmere, odmerek ter pogostost in obdobje nanašanja.
Water shall be analysed at suitable intervals.
Voda se analizira v ustreznih časovnih razmikih.
Intermediate sampling of plant and soil material shall be avoided (except for harvesting in accordance with normal agricultural practice), since removal of plants and soil influence the leaching process.
Vmesno vzorčenje rastlinskega in talnega materiala se ne izvaja (razen pri spravilu v skladu z običajno kmetijsko prakso), ker odstranitev rastlin in tal vpliva na postopek izpiranja.
Precipitation, soil and air temperatures shall be recorded at regular intervals (at least on a weekly base).
Padavine ter temperatura tal in zraka se evidentirajo v rednih časovnih razmikih (vsaj enkrat na teden).
Information on the groundwater table in the experimental fields shall be submitted.
Predložijo se informacije o podtalnici na poskusnih terenih.
Depending on the experimental design, a detailed hydrological characterisation of the test field shall be carried out.
Glede na načrt poskusa se izvede podrobna hidrološka analiza preskusnega terena.
If soil cracking is observed during the study this shall be fully described.
Če se med študijo ugotovijo razpoke v tleh, se podrobno opišejo.
Attention shall be given to the number and the location of water collection devices.
Pozorno se obravnavata število in lokacija naprav za zbiranje vode.
The placement of these devices in the soil shall not result in preferential flow paths.
Naprave niso nameščene na prevladujočih poteh pretoka vode v tleh.
The information provided, taken together with that provided for one or more plant protection products containing the active substance, and other relevant information, shall be sufficient to establish or permit estimation of:
Navedene informacije skupaj z informacijami za eno ali več fitofarmacevtskih sredstev, ki vsebujejo aktivno snov, ter druge ustrezne informacije zadoščajo za določitev ali oceno:
persistence in water systems (bottom sediment and water, including suspended particles);
obstojnosti v vodnih sistemih (usedlina z dna in voda, vključno s suspendiranimi delci);
the extent to which water and sediment organisms are at risk;
ravni tveganj za onesnaženje vode in organizmov v usedlinah;
potential for contamination of surface water and groundwater.
možnosti onesnaženja površinskih voda in podtalnice.
identify the relative importance of the types of processes involved (balance between chemical and biological degradation);
določitev relativnega pomena vrst vključenih postopkov (razmerje med kemijsko in biološko razgradnjo);
where possible, identify the individual components present;
opredelitev posameznih prisotnih sestavin, kadar je mogoče;
permit the residue of concern to which non-target species are or may be exposed, to be defined.
opredelitev pogojno nevarnih ostankov, ki so jim neciljne vrste izpostavljene ali bi jim lahko bile izpostavljene.
The hydrolysis rate of purified active substances shall be determined and reported at 20 °C or 25 °C.
Določi in navede se stopnja hidrolize čiste aktivne snovi pri 20 °C ali 25 °C.
Studies on hydrolytic degradation shall also be performed for degradation and reaction products which account at any time for more than 10 % of the amount of active substance added in the hydrolysis study, unless sufficient information on their degradation is available from the test performed with the active substance.
Študije o hidrolizni razgradnji se izvedejo tudi za razgradne in reakcijske produkte, kadar koli med študijo o hidrolizi predstavljajo več kot 10 % količine dodane aktivne snovi, razen kadar je na podlagi preskusa, izvedenega z aktivno snovjo, na voljo dovolj informacij o njihovi razgradnji.
No additional hydrolysis information on degradates shall be required if they are considered to be stable in water.
Če se razgradni produkti štejejo za obstojne v vodi, v zvezi z njimi niso potrebne dodatne informacije o hidrolizi.
The hydrolysis rate for pH 4, 7 and 9 under sterile conditions in the absence of light shall be determined and reported at 20 °C or 25 °C.
Stopnja hidrolize se za vrednosti pH 4, 7 in 9 določi in navede v sterilnih pogojih in temi pri 20 °C ali 25 °C.
For active substances that are stable or have a low rate of hydrolysis at 20-25 °C, the rate shall be determined at 50 °C, or another temperature above 50 °C.
Za aktivne snovi, ki so pri 20–25 °C obstojne ali imajo nizko stopnjo hidrolize, se stopnja določi pri 50 °C ali pri drugi temperaturi nad 50 °C.
If degradation is observed at 50 °C or above, the degradation rate at at least three other temperatures shall be determined and an Arrhenius plot shall be constructed to permit an estimate to be made of hydrolysis rate at 20 °C and 25 °C.
Če pride pri 50 °C ali več do razgradnje, se stopnja razgradnje določi pri vsaj treh drugih temperaturah, pri čemer se izdela Arrheniusov diagram, s katerim se lahko hidroliza oceni pri 20 °C in 25 °C.
The identity of hydrolysis products formed and the rate constants observed, shall be reported.
Opredelijo in navedejo se nastali produkti hidrolize in njihovo stalno razmerje.
The estimated DegT50 values shall be reported for 20 °C or 25 °C.
Ocenjene vrednosti DegT50 se navedejo za 20 °C ali 25 °C.
For compounds with a molar (decadic) absorption coefficient (ε) > 10 L × mol–1 × cm–1 at a wavelength (λ) ≥ 295 nm direct phototransformation of purified active substances shall be determined and reported unless the applicant shows that contamination of surface water will not occur.
Za snovi z molskim (dekadnim) absorpcijskim koeficientom (ε) > 10 l × mol–1 × cm–1 pri valovni dolžini (λ) ≥ 295 nm se določi in navede neposredna fototransformacija čistih aktivnih snovi, razen če vlagatelj dokaže, da ne bo prišlo do onesnaženja površinskih voda.
Studies on direct photochemical degradation shall also be performed for metabolites, breakdown and reaction products which account at any time for more than 10 % of the amount of active substance added in the photolysis study, unless sufficient information on their degradation is available from the test performed with the active substance.
Študije o neposredni fotokemijski razgradnji se izvedejo tudi za metabolite ter razgradne in reakcijske produkte, ki kadar koli med študijo o fotolizi predstavljajo več kot 10 % količine dodane aktivne snovi, razen kadar je na podlagi preskusa, izvedenega z aktivno snovjo, na voljo dovolj informacij o njihovi razgradnji.
No additional photolysis information on degradates shall be required if they are considered to be stable under photolytic conditions.
Če se razgradni produkti štejejo za obstojne v fotoliznih pogojih, v zvezi z njimi niso potrebne dodatne informacije o fotolizi.
The direct phototransformation in purified, (for example distilled) buffered water using artificial light under sterile conditions, if necessary using a solubiliser, shall be determined and reported.
Določi in navede se neposredna fototransformacija v čisti (na primer destilirani) pufrski vodi pri umetni svetlobi v sterilnih pogojih in po potrebi s topljencem.
In the first theoretical step a maximum possible photolysis rate shall be estimated based on the molar extinction coefficient of the active substance.
V prvem teoretičnem koraku se na podlagi koeficienta molekulske ekstinkcije aktivne snovi oceni največja možna stopnja fotolize.
If photolysis is considered to be a potentially significant degradation pathway, photolysis experiments for range finding shall be carried out (tier 2).
Če je ugotovljeno, da je fotoliza morebitno pomembna pot razgradnje, se izvedejo poskusi za ugotavljanje območja (stopnja 2).
Determination of quantum yield and direct photolysis route/rate (tiers 3 and 4) shall be carried out for active substances where tier 2 indicates significant photolysis.
Količina in pot/stopnja neposredne fotolize (stopnji 3 in 4) se določita za aktivne snovi, kadar je na stopnji 2 ugotovljena pomembna fotoliza.
The identity of breakdown products formed which exceed 10 % of the applied test substance at any time during the study, a mass balance to account for at least 90 % of the applied radioactivity, as well as photochemical half-life (DT50) shall be reported.
Navedejo se nastali razgradni produkti, ki kadar koli med študijo presegajo 10 % nanesene preskusne snovi, masno ravnotežje, s katerim se lahko utemelji najmanj 90 % uporabljene radioaktivnosti, in fotokemijska razpolovna doba (DT50).
Studies on indirect photochemical degradation may be submitted where there are indications from other available data that route and rate of degradation in the water phase can be significantly influenced by indirect photodegradation.
Študije o posredni fotokemijski razgradnji se lahko predložijo, kadar drugi razpoložljivi podatki kažejo, da lahko posredna fotorazgradnja pomembno vpliva na pot in stopnjo razgradnje v fazi, ki vključuje vodo.
Studies shall be performed in an aqueous system containing organic (humic substances) and inorganic (salts) compounds in a composition that is typical for natural surface waters.
Študije se izvedejo v vodnem sistemu, ki vsebuje organske (huminske snovi) in anorganske (soli) sestavine v sestavi, ki je značilna za naravne površinske vode.
The ‘ready biodegradability’ test shall be performed.
Opravi se preskus „hitre biološke razgradnje“.
If no such test is provided, the active substance shall by default be considered not ‘readily biodegradable’.
Če takšnega preskusa ni, se šteje, da aktivna snov ni „hitro biološko razgradljiva“.
identify individual components present, which at any time account for more than 10 % of the amount of active substance added, including, where possible, non-extractable residues;
opredelitev posameznih sestavin, ki kadar koli predstavljajo več kot 10 % količine dodane aktivne snovi, vključno z neekstrabilnimi ostanki, kadar je mogoče;
identify individual components present, which account for more than 5 % of the amount of active substance added in at least two sequential measurements, where possible;
opredelitev posameznih sestavin, ki pri vsaj dveh zaporednih meritvah predstavljajo več kot 5 % količine dodane aktivne snovi, kadar je mogoče;
identify individual components (> 5 %) for which at the end of the study the maximum of formation is not yet reached, where possible;
opredelitev posameznih sestavin (> 5 %), ki se ob koncu študije še ne tvorijo v največjem obsegu, kadar je mogoče;
identify or characterise, where possible, other individual components;
opredelitev ali določitev lastnosti, kadar je mogoče, drugih posameznih sestavin;
permit, where relevant, the sediment residue of concern and to which non-target species are or may be exposed, to be defined.
opredelitev pogojno nevarnih ostankov usedlin, ki so jim neciljne vrste izpostavljene ali bi jim lahko bile izpostavljene, kadar je ustrezno.
Studies on aerobic mineralisation in surface water shall be provided unless the applicant shows that contamination of open water (freshwater, estuarine and marine) will not occur.
Študije o aerobni mineralizaciji v površinskih vodah se zagotovijo, razen če vlagatelj dokaže, da ne bo prišlo do onesnaženja odprtih voda (sladke vode, rečnih ustij in morske vode).
The rate of degradation and the pathway or pathways shall be reported either for a ‘pelagic’ test system or for a ‘suspended sediment’ system.
Stopnja razgradnje in pot ali poti se navedejo za „pelagični“ preskusni sistem ali za sistem „suspendiranih usedlin“.
Where relevant, additional test systems, which differ with respect to organic carbon content, texture or pH shall be used.
Kadar je ustrezno, se uporabijo dodatni preskusni sistemi, ki se razlikujejo glede na vsebnost organskega ogljika, teksturo ali vrednost pH.
Results obtained shall be presented in the form of schematic drawings showing the pathways involved, and in the form of balance sheets which show the distribution of radio-label in water and, where relevant, sediment as a function of time, as between:
Dobljeni rezultati se predstavijo v obliki shematičnega prikaza zadevnih poti in v obliki razpredelnic, ki prikazujejo razporeditev radioaktivnih markerjev v vodi in, kadar je ustrezno, v usedlini glede na čas za naslednje snovi:
individual identified transformation products.
posamezne opredeljene transformacijske produkte.
The duration of the study shall not exceed 60 days unless the semi-continuous procedure with periodical renewal of the test suspension is applied.
Študija traja največ 60 dni, razen če se uporabi polkontinuiran postopek z obdobnim obnavljanjem preskusne suspenzije.
However, the period for the batch test may be extended to a maximum of 90 days, if the degradation of the test substance has started within the first 60 days.
Če pa se razgradnja preskusne snovi začne v prvih 60 dneh, se lahko serijski preskus podaljša do največ 90 dni.
The information provided, together with other relevant information, shall be sufficient to:
Navedene informacije skupaj z drugimi ustreznimi informacijami zadoščajo za:
identify individual components present which at any time account for more than 10 % of the amount of active substance added, including, where possible, non-extractable residues;
opredelitev posameznih sestavin, ki kadar koli predstavljajo več kot 10 % količine dodane aktivne snovi, vključno z neekstrabilnimi ostanki, kadar je mogoče;
identify individual components present which account for more than 5 % of the amount of active substance added in at least two sequential measurements, where possible;
opredelitev posameznih sestavin, ki pri vsaj dveh zaporednih meritvah predstavljajo več kot 5 % količine dodane aktivne snovi, kadar je mogoče;
identify or characterise, where possible, also other individual components present;
opredelitev ali določitev lastnosti, kadar je mogoče, tudi drugih posameznih prisotnih sestavin;
define the sediment residue of concern, to which non-target species are or may be exposed.
opredelitev pogojno nevarnih ostankov usedlin, ki so jim neciljne vrste izpostavljene ali bi jim lahko bile izpostavljene.
Where a reference is made to non-extractable residues these shall be defined as chemical species originating from active substances used in accordance with good agricultural practice that cannot be extracted by methods which do not significantly change the chemical nature of these residues or the nature of the sediment matrix.
Pri sklicevanju na neekstrabilne ostanke so ti opredeljeni kot kemijske snovi, ki so nastale iz aktivnih snovi, ki se uporabljajo v skladu z dobro kmetijsko prakso, in jih ni mogoče ekstrahirati z metodami, ki bistveno ne spremenijo kemijske oblike teh ostankov ali lastnosti sedimentnega matriksa.
The water/sediment study shall be reported unless the applicant shows that contamination of surface water will not occur.
Študija o vodi/usedlini se navede, razen če vlagatelj dokaže, da ne bo prišlo do onesnaženja površinskih voda.
The degradation pathway or pathways shall be reported for two water/sediment systems.
Pot ali poti razgradnje se navedejo za dva sistema vode/usedline.
The two sediments selected shall differ with respect to organic carbon content and texture, and where relevant, with respect to pH.
Obe izbrani usedlini se razlikujeta glede na vsebnost organskega ogljika in teksturo ter, kadar je ustrezno, glede na vrednost pH.
Results obtained shall be presented in the form of schematic drawings showing the pathways involved, and in the form of balance sheets which show the distribution of radio-label in water and sediment as a function of time, as between:
Dobljeni rezultati se predstavijo v obliki shematičnega prikaza zadevnih poti in v obliki razpredelnic, ki prikazujejo razporeditev radioaktivnih markerjev v vodi in usedlini glede na čas za naslednje snovi:
individual identified transformation products;
posamezne opredeljene transformacijske produkte;
non-extractable residues in sediment.
neekstrabilne ostanke v usedlinah.
The duration of the study shall be at least 100 days.
Študija traja vsaj 100 dni.
It shall be longer where this is necessary to establish the degradation pathway and water/sediment distribution pattern of the active substance and its metabolites, breakdown and reaction products.
Študija je daljša, kadar je to potrebno za določitev poti razgradnje ter vzorca porazdelitve aktivne snovi in njenih metabolitov ter razgradnih in reakcijskih produktov v vodi/usedlini.
If more than 90 % of the active substance is degraded before the period of 100 days expires, the test duration may be shorter.
Če se pred koncem 100-dnevnega obdobja razgradi več kot 90 % aktivne snovi, je lahko preskus krajši.
The degradation pattern of potentially relevant metabolites occurring within the water/sediment study shall be established either by extension of the study for the active substance, or by conducting a separate study for potentially relevant metabolites.
Vzorec razgradnje potencialno relevantnih metabolitov v okviru študije o vodi/usedlini se določi z razširitvijo študije za aktivno snov ali z izvedbo ločene študije za potencialno relevantne metabolite.
The same general provisions as provided under point 7.2.2.3 apply.
Veljajo splošne določbe iz točke 7.2.2.3.
If photochemical degradation is of importance a water/sediment study under influence of a light/dark regime may additionally be provided.
Če je fotokemijska razgradnja pomembna, se lahko zagotovi tudi študija o vodi/usedlini pod vplivom svetlobnega režima.
The vapour pressure of purified active substance, as provided under point 2.2, shall be reported.
Navede se parni tlak čiste aktivne snovi, kot je določeno v točki 2.2.
An estimate of the half-life in the upper atmosphere of the active substance and any volatile metabolites, breakdown and reaction products, formed in soil or natural water systems, shall be calculated and reported.
Izračuna in navede se ocena razpolovne dobe v zgornji atmosferi za aktivno snov in vse hlapne metabolite ter razgradne in reakcijske produkte, ki nastanejo v tleh ali v naravnih vodnih sistemih.
Estimates of active substance upper atmospheric half-lives, based on monitoring data shall also be calculated, when monitoring data that enable this to be done, are available.
Poleg tega se ocene razpolovnih dob aktivne snovi v zgornji atmosferi izračunajo na podlagi podatkov o spremljanju, če so na voljo podatki o spremljanju, ki to omogočajo.
If the trigger for volatilisation, Vp = 10–5 Pa (plant) or 10–4 Pa (soil) at a temperature of 20 °C, is exceeded and (drift) mitigation measures are required, data from confined experiments may be reported.
Če je prag za izhlapevanje, tj. Vp = 10–5 Pa (rastline) ali 10–4 Pa (tla) pri temperaturi 20 °C, presežen in je treba sprejeti ukrepe za ublažitev (zanašanja), se lahko navedejo podatki iz omejenih poskusov.
If needed, experiments to determine deposition following volatilisation may be provided.
Po potrebi se lahko zagotovijo poskusi za določitev usedanja po izhlapevanju.
The national competent authorities shall be consulted to decide whether this information is necessary.
O potrebi po teh informacijah se izvede posvetovanje z nacionalnimi pristojnimi organi.
For substances that are applied in high amounts, the following effects shall be considered:
Za snovi, ki se nanašajo v velikih količinah, se obravnavajo naslednji učinki:
global warming potential (GWP);
možnost globalnega segrevanja,
ozone depleting potential (OPD);
možnost škodljivosti za ozon,
photochemical ozone creation potential (POCP);
možnost tvorbe fotokemijskega ozona,
accumulation in the troposphere;
kopičenje v troposferi,
acidification potential (AP);
možnost zakisljevanja,
eutrophication potential (EP).
možnost evtrofikacije.
The residue definition relevant for risk assessment for each compartment shall be defined to include all components (active substance, metabolites, breakdown and reaction products) that were identified in accordance with the criteria referred to in this Section.
Opredelitev ostanka za oceno tveganja za posamezni del se določi tako, da vključuje vse sestavine (aktivno snov, metabolite ter razgradne in reakcijske produkte), ki so bile ugotovljene v skladu z merili iz tega oddelka.
The chemical composition of residues occurring in soil, groundwater, surface water (freshwater, estuarine and marine), sediment and air, resulting from use, or proposed use, of a plant protection product containing the active substance, shall be taken into account.
Upošteva se kemijska sestava ostankov v tleh, podtalnici, površinski vodi (sladki vodi, rečnih ustjih in morski vodi), usedlini in zraku, ki so posledica uporabe ali predlagane uporabe fitofarmacevtskega sredstva, ki vsebuje aktivno snov.