natgillin/translations-raw huggingface dataset:
A full justification for the proposed MRLs must be provided, including, where relevant, full details of the statistical analysis used.
Predložiti je treba popolno utemeljitev predlaganih mejnih vrednosti ostankov, skupaj z vsemi podrobnostmi o uporabljenih statističnih metodah, kadar je to relevantno.
When judging which compounds are to be included in the residue definition, account has to be taken of the toxicological significance of the compounds, amounts likely to be present and the practicality of the analytical methods proposed for post-registration control and monitoring purposes.
Pri oceni, katere spojine naj bodo vključene v opredelitev ostanka, je treba upoštevati toksikološki pomen spojin, verjetne prisotne količine ter praktičnost predlagane analitske metode za nadzor in spremljanje po registraciji.
Proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses
Predlagane karence pred spravilom za predvidene uporabe ali obdobja prepovedi uporabe ali obdobja shranjevanja pri uporabi po spravilu
A full justification for the proposals must be provided.
Predložiti je treba popolno utemeljitev predlogov.
Estimation of the potential and actual exposure through diet and other means
Ocene potencialne in dejanske izpostavljenosti prek prehrane in drugih sredstev
Consideration will be given to the calculation of a realistic prediction of dietary intake.
Upoštevati je treba izračun realistične napovedi vnosa s prehrano.
This may be done in a step-wise fashion leading to an increasingly realistic prediction of intake.
To se lahko naredi na postopen način, ki omogoča bolj realistično napoved vnosa.
Where relevant, other sources of exposure such as residues arising from the use of medicines or veterinary drugs have to be taken into account.
Kadar je to relevantno, je treba upoštevati druge vire izpostavitve, kot so ostanki v zdravilih ali veterinarskih zdravilih.
Summary and evaluation of residue behaviour
Povzetek in ocena obnašanja ostankov
A summary and evaluation of all data presented in this Section shall be carried out in accordance with the guidance given by the competent authorities of the Member States concerning the format of such summaries and evaluations.
Pripravita se povzetek in ocena vseh podatkov, predstavljenih v tem oddelku, v skladu s smernicami pristojnih organov držav članic o formatu takih povzetkov in ocen.
It shall include a detailed and critical assessment of those data in the context of relevant evaluative and decision-making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the data base.
Povzetek vključuje podrobno in kritično oceno navedenih podatkov v okviru relevantnih meril in smernic za ocenjevanje in odločanje, zlasti v zvezi s tveganjem za ljudi in živali, ki iz tega izvira ali bi lahko izviralo, ter z obsegom, kakovostjo in zanesljivostjo podatkovne zbirke.
In particular, the toxicological significance of any non-mammalian metabolites must be addressed.
Še zlasti je treba obravnavati toksikološki pomen vseh metabolitov pri nesesalcih.
A schematic diagram shall be prepared of the metabolic pathway in plants and animals with a brief explanation of the distribution and chemical changes involved.
Pripravi se shema presnove pri rastlinah in živalih s kratko razlago porazdelitve in vključenih kemičnih sprememb.
The information provided, taken together with that for one or more preparations containing the active substance, must be sufficient to permit an assessment of the fate and behaviour of the active substance in the environment, and of the non-target species likely to be at risk from exposure to the active substance, its metabolites, degradation and reaction products, where they are of toxicological or environmental significance.
Predložene informacije, skupaj z informacijami za enega ali več pripravkov, ki vsebujejo aktivno snov, morajo zadoščati za oceno vpliva na končno stanje in obnašanje aktivne snovi v okolju in za opredelitev neciljnih vrst, ki so lahko ogrožene zaradi izpostavljenosti aktivni snovi, njenim metabolitom, razgradnim in reakcijskim produktom, kadar so toksikološko ali okoljsko pomembni.
In particular, the information provided for the active substance, together with other relevant information, and that provided for one or more preparations containing it shall be sufficient to:
Predložene informacije o aktivni snovi, skupaj z drugimi relevantnimi informacijami za enega ali več pripravkov, ki vsebujejo aktivno snov, zadoščajo za:
decide whether, or not, the active substance can be approved,
odločitev o odobritvi aktivne snovi,
specify the pictograms, signal words and relevant hazard and precautionary statements for the protection of the environment, which are to be included on packaging (containers),
določitev piktogramov, opozorilnih besed in relevantnih stavkov o nevarnosti in previdnostnih stavkov za zaščito okolja, ki morajo biti na embalaži (posodah),
predict the distribution, fate, and behaviour in the environment of the active substance and relevant metabolites, degradation and reaction products as well as the times courses involved,
predvidevanje porazdelitve, končnega stanja in obnašanja aktivne snovi, relevantnih metabolitov, razgradnih in reakcijskih produktov v okolju, kakor tudi časovnih potekov teh procesov,
identify non-target species and populations for which hazards arise because of potential exposure, and
opredelitev neciljnih vrst in populacij, ki so lahko ogrožene zaradi morebitne izpostavljenosti, ter
identify measures necessary to minimise contamination of the environment and impact on non-target species.
opredelitev ukrepov, potrebnih za zmanjšanje onesnaževanja okolja in vpliva na neciljne vrste.
A detailed description (specification) of the material used, as provided for under point 1.11 must be provided.
Predložiti je treba podroben opis (specifikacijo) uporabljene snovi, kot je določeno v točki 1.11.
Where testing is done using active substance the material used shall be of that specification that will be used in the manufacture of preparations to be authorised except where radio-labelled material is used.
Kadar se testira aktivna snov, se uporabi snov, ki po specifikaciji ustreza snovi, ki se bo uporabljala pri proizvodnji pripravkov, ki so v postopku registracije, razen kadar se uporablja snov, označena z radioaktivnimi markerji.
Where studies are conducted using active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using active substance as manufactured, unless it can be justified that the test material used is essentially the same for the purposes of environmental testing and assessment.
Kadar se izvajajo študije o aktivne snovi, proizvedene v laboratoriju ali v poskusni proizvodnji, jih je treba ponoviti s tehnično aktivno snovjo, razen če je mogoče utemeljiti, da je uporabljena testna snov s stališča ekotoksikološkega testiranja in ocene enaka.
Where radio-labelled test material is used, radio-labels shall be positioned at sites (one or more as necessary), to facilitate elucidation of metabolic and degradative pathways and to facilitate investigation of the distribution of the active substance and of its metabolite, reaction and degradation products in the environment.
Kadar se uporablja testna snov, označena z radioaktivnimi markerji, se radioaktivni markerji postavijo na enega ali (po potrebi) več mest, ki omogočajo pojasnitev poti presnove in razgradnje ter porazdelitev aktivne snovi, njenih metabolitov, reakcijskih in razgradnih produktov v okolju.
It may be necessary to conduct separate studies for metabolites, degradation or reaction products, where these products can constitute a relevant risk to non-target organisms or to the quality of water, soil and air and where their effects cannot be evaluated by the available results relating to the active substance.
Ločene študije za metabolite, razgradne ali reakcijske produkte je morda treba izvesti, kadar ti produkti lahko predstavljajo resno tveganje za neciljne organizme ali za kakovost vode, tal in zraka in kadar se njihovi učinki ne morejo oceniti na podlagi razpoložljivih rezultatov za aktivno snov.
Before such studies are performed the information from the Sections 5 and 6 has to be taken into account.
Pred izvedbo teh študij je treba upoštevati informacije iz oddelkov 5 in 6.
Where relevant, tests shall be designed and data analysed using appropriate statistical methods.
Kadar je to relevantno, se načrtujejo testi in analizirajo podatki ob uporabi primernih statističnih metod.
Full details of the statistical analysis shall be reported (e.g. all point estimates shall be given with confidence intervals, exact p-values shall be given rather than stating significant/non-significant).
Navedejo se vse podrobnosti statistične analize (npr. vse ocenjene vrednosti z intervalom zaupanja, natančne p-vrednosti namesto navajanja statistično značilno/neznačilno).
Fate and behaviour in soil
Končno stanje in obnašanje v tleh
All relevant information on the type and the properties of the soil used in the studies, including pH, organic carbon content, cation exchange capacity, particle size distribution and water holding capacity, at pF = 0 and pF = 2,5 has to be reported in accordance with relevant ISO or other international standards.
Vse relevantne informacije o vrsti in značilnosti tal, uporabljene v študijah, vključno z vrednostjo pH, vsebnostjo organskega ogljika, sposobnostjo izmenjave kationov, teksturo in sposobnostjo zadrževanja vode pri pF = 0 in pF = 2,5, je treba navesti v skladu z ustreznimi standardi ISO ali drugimi mednarodnimi standardi.
The microbial biomass of soils used for laboratory degradation studies must be determined just prior to the commencement and at the end of the study.
Neposredno pred začetkom in na koncu študije je treba določiti mikrobno biomaso tal, uporabljenih v laboratorijskih študijah o razgradnji.
It is recommended to use as much as possible the same soils throughout all laboratory soil studies.
Priporočljivo je čim več uporabljati vzorce istih tal med vsemi laboratorijskimi študijami o tleh.
The soils used for degradation or mobility studies must be selected such that they are representative of the range of soils typical of the various EU regions where use exists or is anticipated, and be such that:
Vzorci tal, ki se uporabijo v študijah o razgradnji ali mobilnosti, morajo predstavljati vrste tal, ki so tipične za različna območja EU, kjer se aktivna snov uporablja ali se predvideva njena uporaba, in morajo:
they cover a range of organic carbon content, particle size distribution and pH values, and
zajemati različne vsebnosti organskega ogljika, teksturne razrede in vrednosti pH, in
where on the basis of other information, degradation or mobility are expected to be pH dependent (e.g. solubility and hydrolysis rate — points 2.7 and 2.8), they cover the following pH ranges:
kadar se na podlagi drugih informacij pričakuje, da bo razgradnja ali mobilnost odvisna od pH (npr. topnost in stopnja hidrolize – točki 2.7 in 2.8), zajemati naslednja območja vrednosti pH:
6 to 7, and
6 do 7 in
8 (approximately).
(približno) 8.
Soils used must, wherever possible, be freshly sampled.
Uporabljeni vzorec tal mora biti, kadar je to mogoče, ob vzorčenju svež.
If use of stored soils is unavoidable, storage shall be properly carried out for a limited time under defined and reported conditions.
Če se ni mogoče izogniti uporabi shranjenega vzorca tal, se ta ustrezno shrani za omejeno obdobje pri opredeljenih in navedenih pogojih.
Soils stored for longer periods of time can only be used for adsorption/desorption studies.
Vzorci tal, shranjeni v daljšem obdobju, se lahko uporabijo le za študije o adsorpciji/desorpciji.
The soil chosen to begin studying shall not have extreme characteristics with respect to parameters such as particle size distribution, organic carbon content and pH.
Vzorec tal, izbran za začetek študij, nima skrajnih značilnosti glede teksture, vrednosti organskega ogljika in pH.
Soils shall be collected and handled in accordance with ISO 10381-6 (Soil quality — Sampling — Guidance on the collection, handling and storage of soil for the assessment of microbial processes in the laboratory).
Vzorci tal se odvzamejo in pripravijo v skladu s standardom ISO 10381-6 (Kakovost zemlje – Vzorčenje – Smernice za odvzem, pripravo in shranjevanje vzorcev tal za oceno mikrobioloških postopkov v laboratoriju).
Any deviations must be reported and justified.
Navesti in utemeljiti je treba vsa odstopanja.
Field studies shall be carried out in conditions as close to normal agricultural practice as possible on a range of soil types and climatic conditions representative of the area(s) of use.
Terenske študije se izvedejo v pogojih, ki so čim bolj podobni običajni kmetijski praksi glede vrst tal in podnebnih pogojev, reprezentativnih za območja uporabe.
Weather conditions shall be reported in cases where field studies are conducted.
Vremenske razmere se navedejo, kadar se izvajajo terenske študije.
Route and rate of degradation
Pot in hitrost razgradnje
Route of degradation
Pot razgradnje
The data and information provided, together with other relevant data and information, shall be sufficient to:
Navedeni podatki in informacije, skupaj z drugimi relevantnimi podatki in informacijami, zadoščajo za:
identify, where feasible, the relative importance of the types of process involved (balance between chemical and biological degradation),
določitev, kadar je mogoče, relativne pomembnosti vrst vključenih postopkov (ravnotežje med kemijsko in biološko razgradnjo),
identify the individual components present which at any time account for more than 10 % of the amount of active substance added, including, where feasible, non-extractable residues,
opredelitev prisotnih posameznih sestavin, ki v katerem koli trenutku predstavljajo ve kot 10 % količine dodane aktivne snovi, vključno z neekstrabilnimi ostanki, kadar je izvedljivo,
identify where possible also individual components present which account for less than 10 % of the amount of active substance added,
opredelitev prisotnih posameznih sestavin, ki predstavljajo manj kot 10 % količine dodane aktivne snovi, kadar je mogoče,
establish the relative proportions of the components present (mass balance), and
določitev relativnih razmerij prisotnih sestavin (masno ravnotežje) in
permit the soil residue of concern and to which non-target species are or may be exposed, to be defined.
opredelitev problematičnih ostankov v tleh, ki so jim neciljne vrste izpostavljene ali lahko izpostavljene.
Where a reference is made to non-extractable residues these are defined as chemical species originating from pesticides used in accordance with good agricultural practice that cannot be extracted by methods which do not significantly change the chemical nature of these residues.
Pri sklicu na neekstrabilne ostanke se ti opredelijo kot kemijske snovi, ki izvirajo iz pesticidov, ki se uporabljajo v skladu z običajno kmetijsko prakso, in se ne morejo ekstrahirati z metodami, ki bistveno ne spreminjajo kemijske oblike teh ostankov.
These non-extractable residues are not considered to include fragments through metabolic pathways leading to natural products.
Pri teh neekstraktibilnih ostankih se šteje, da ne zajemajo delcev skozi metabolne poti, ki vodijo v naravne produkte.
Aerobic degradation
Aerobna razgradnja
The degradation pathway or pathways must always be reported except where the nature and manner of use of preparations containing the active substance, preclude soil contamination such as uses on stored products or wound healing treatments for trees.
Vedno je treba navesti pot ali poti razgradnje, razen kadar narava ali način uporabe pripravkov, ki vsebujejo aktivno snov, preprečuje onesnaženje tal, kot je uporaba na shranjenih proizvodih ali za premaze za zdravljenje poškodb na drevesih.
The degradation pathway or pathways must be reported for one soil.
Pot ali poti razgradnje je treba navesti za eno vrsto tal.
Results obtained must 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 as a function of time, as between:
Dobljene rezultate je treba predstaviti v obliki shematičnega prikaza vključenih poti in v obliki razpredelnic, ki prikazujejo razporeditev radioaktivnih markerjev in naslednjih snovi glede na čas:
active substance,
aktivne snovi,
volatile compounds other than CO2,
hlapnih spojin, razen CO2,
individual identified transformation products,
posameznih opredeljenih transformacijskih produktov,
extractable substances not identified, and
ekstrabilnih snovi, ki niso opredeljene, in
non-extractable residues in soil.
neekstrabilnih ostankov v tleh.
The investigation of degradation pathways must include all feasible steps to characterise and quantify non-extractable residues formed after 100 days when exceeding 70 % of the applied dose of the active substance.
Pri preučevanju poti razgradnje je treba vključiti vse izvedljive korake za opredelitev lastnosti in količine neekstrabilnih ostankov, ki nastanejo po 100 dneh, če presegajo 70 % nanesenega odmerka aktivne snovi.
The techniques and methodologies applied are best selected on a case-by-case basis.
Uporabljene tehnike in metodologije je najbolje izbrati za vsak posamezen primer.
A justification must be provided where the compounds involved are not characterised.
Kadar spojine niso opredeljene, je treba predložiti utemeljitev.
The duration of the study is normally 120 days, except where after a shorter period the levels of non-extractable residues and CO2 are such that they can be extrapolated in a reliable way to 100 days.
Študija običajno traja 120 dni, razen kadar je raven neekstrabilnih ostankov in CO2 po krajšem obdobju taka, da jih je mogoče ekstrapolirati na zanesljiv način po 100 dneh.
SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides [13].7.1.1.1.2. Supplementary studies
SETAC – Postopki za ocenjevanje končnega stanja pesticidov v okolju in njihove ekotoksičnosti [13].7.1.1.1.2 Dopolnilne študije
Anaerobic degradation
Anaerobna razgradnja
An anaerobic degradation study must be reported unless it can be justified that exposure of the plant protection products containing the active substance to anaerobic conditions is unlikely to occur.
Študijo o anaerobni razgradnji je treba navesti, razen kadar je mogoče utemeljiti, da je majhna verjetnost izpostavitve fitofarmacevtskega sredstva, ki vsebuje aktivno snov, anaerobnim pogojem.
Test conditions and test guideline
Testni pogoji in smernice za testiranje
The same provisions as provided for under the corresponding paragraphs of point 7.1.1.1.1 apply.
Uporabljajo se iste določbe kot iz ustreznih odstavkov točke 7.1.1.1.1.
Soil photolysis
Fotoliza tal
A soil photolysis study must be reported unless it can be justified that deposition of the active substance at the soil surface is unlikely to occur.
Študijo o fotolizi tal je treba navesti, razen kadar je mogoče utemeljiti, da je majhna verjetnost depozicije aktivne snovi na površini tal.
SETAC — Procedures for assessing the Environmental fate and ecotoxicity of pesticides.
SETAC – Postopki za ocenjevanje končnega stanja pesticidov v okolju in njihove ekotoksičnosti.
Rate of degradation
Hitrost razgradnje
Laboratory studies
Laboratorijske študije
The soil degradation studies shall provide best possible estimates of the time taken for degradation of 50 % and 90 % (DT50lab and DT90lab), of the active substance, and of relevant metabolites, degradation and reaction products under laboratory conditions.
Študije o razgradnji v tleh zagotovijo najboljšo možno oceno časa za razgradnjo 50 % in 90 % (DT50lab in DT90lab) aktivne snovi, relevantnih metabolitov ter razgradnih in reakcijskih produktov v laboratorijskih pogojih.
The rate of degradation in soil must always be reported, except where the nature and manner of use of plant protection products containing the active substance preclude soil contamination such as uses on stored products or wound healing treatments for trees.
Vedno je treba navesti hitrost razgradnje v tleh, razen kadar narava ali način uporabe fitofarmacevtskih sredstev, ki vsebujejo aktivno snov, preprečuje onesnaženje tal, kot je uporaba na shranjenih proizvodih ali za premaze za zdravljenje poškodb na drevesih.
The rate of aerobic degradation of the active substance in three soil types additional to that referred to in point 7.1.1.1.1 must be reported.
Navesti je treba hitrost aerobne razgradnje aktivne snovi v treh vrstah tal poleg tiste iz točke 7.1.1.1.1.
In order to investigate the influence of temperature on degradation, one additional study at 10 °C has to be performed on one of the soils used for the investigation of degradation at 20 °C until a validated EU calculation model for the extrapolation of degradation rates at low temperatures is available.
Za preučitev vpliva temperature na razgradnjo je treba opraviti dodatno študijo pri 10 °C na eni od vrst tal, uporabljenih za preučitev razgradnje pri 20 °C, dokler ni na voljo potrjen model izračuna EU za ekstrapolacijo hitrosti razgradnje pri nižjih temperaturah.
The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires.
Študija običajno traja 120 dni, razen kadar se več kot 90 % aktivne snovi razgradi pred iztekom navedenega obdobja.
Similar studies for three soil types must be reported for all relevant metabolites, degradation and reaction products which occur in soil and which at any time during the studies account for more than 10 % of the amount of active substance added, except where their DT50 values were able to be determined from the results of the degradation studies with the active substance.
Navesti je treba podobne študije za tri vrste tal za vse relevantne metabolite, razgradne in reakcijske produkte, ki se nahajajo v tleh in ki kadar koli med študijo predstavljajo več kot 10 % količine dodane aktivne snovi, razen kadar je mogoče njihove vrednosti DT50 določiti iz rezultatov študij o razgradnji aktivne snovi.
SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.
SETAC – Postopki za ocenjevanje končnega stanja pesticidov v okolju in njihove ekotoksičnosti.
The rate of anaerobic degradation of the active substance must be reported where an anaerobic study has to be performed in accordance with point 7.1.1.1.2.
Kadar je treba v skladu s točko 7.1.1.1.2 izvesti študijo o anaerobni razgradnji, je treba navesti hitrost anaerobne razgradnje aktivne snovi.
The rate of anaerobic degradation of the active substance must be carried out in the soil used in the anaerobic study performed in accordance with point 7.1.1.1.2.
Hitrost anaerobne razgradnje aktivne snovi je treba določiti v vzorcu tal, ki se uporablja v študiji o anaerobni razgradnji v skladu s točko 7.1.1.1.2.
Similar studies for one soil must be reported for all relevant metobolites, degradation and reaction products which occur in soil and which at any time during the studies account for more than 10 % of the amount of active substance added, except where their DT50 values were able to be determined from the results of the degradation studies with the active substance.
Navesti je treba podobne študije za eno vrsto tal za vse relevantne metabolite, razgradne in reakcijske produkte, ki se nahajajo v tleh in ki kadar koli med študijo predstavljajo več kot 10 % količine dodane aktivne snovi, razen kadar je mogoče njihove vrednosti DT50 določiti iz rezultatov študij o razgradnji aktivne snovi.
Field studies
Terenske študije
Soil dissipation studies
Študije o razpadu v tleh
The soil dissipation studies shall provide estimates of the time taken for dissipation of 50 % and 90 % (DT50f and DT90f), of the active substance under field conditions.
Študije o razpadu v tleh omogočajo oceno časa za razpad 50 % in 90 % (DT50f in DT90f) aktivne snovi pri terenskih pogojih.
Where relevant, information on relevant metabolites, degradation and reaction products must be reported.
Kadar je relevantno, je treba navesti informacije o relevantnih metabolitih ter razgradnih in reakcijskih produktih.