natgillin/translations-raw huggingface dataset:
The tests have to be conducted in those conditions where DT50lab determined at 20 °C and at a moisture content of the soil related to a pF value of 2 to 2,5 (suction pressure) is greater than 60 days.
Teste je treba izvajati v pogojih, ko je vrednost DT50lab pri 20 °C in vsebnosti vlage v tleh, ki ustreza vrednosti pF med 2 in 2,5 (vlečni tlak), daljši od 60 dni.
Where plant protection products containing the active substance are intended to be used in cold climatic conditions, the tests have to be conducted where DT50lab, determined at 10 °C and at a moisture content of the soil related to a pF value of 2 to 2,5 (suction pressure) is greater than 90 days.
Kadar je predvidena uporaba fitofarmacevtskih sredstev, ki vsebujejo aktivno snov, v hladnih podnebnih razmerah, je treba teste izvajati v pogojih, ko je vrednost DT50lab pri 10 °C in vsebnosti vlage v tleh, ki ustreza vrednosti pF med 2 in 2,5 (vlečni tlak), daljši od 90 dni.
Individual studies on a range of representative soils (normally four different types) must be continued until > 90 % of the amount applied have dissipated.
Posamezne študije na številnih reprezentativnih vrstah tal (običajno štiri različne vrste) se morajo nadaljevati, dokler ne razpade več kot 90 % nanesene količine snovi.
The maximum duration of the studies is 24 months.
Študije lahko trajajo največ 24 mesecev.
Soil residue studies
Študije o ostankih v tleh
Soil residue studies shall provide estimates of the soil residue levels at harvest or at time of sowing or planting succeeding crops.
Študije o ostankih v tleh omogočijo ocene koncentracij ostankov v tleh pri spravilu ali setvi ali sajenjem naslednjih kultur.
Soil residue studies must be reported where DT50lab is greater than one-third of the period between the application and harvest and where absorption by the succeeding crop is possible, except where soil residues at sowing or planting of a succeeding crop can be reliably estimated from the data of the soil dissipation studies or where it can be justified that these residues can not be phytotoxic to or leave unacceptable residues in rotational crops.
Študije o ostankih v tleh je treba navesti, kadar je DT50lab daljši od ene tretjine obdobja med nanosom in spravilom in kadar je mogoča absorpcija v naslednjih kulturah, razen kadar je mogoče ostanke v tleh pri setvi ali sajenju naslednjih kultur zanesljivo oceniti iz podatkov študij o razpadu v tleh ali kadar je mogoče utemeljiti, da ti ostanki niso fitotoksični ali da so prisotni v nesprejemljivih količinah v naslednjih kulturah.
Individual studies must be continued until harvest or time of sowing or planting succeeding crops, unless > 90 % of the amount applied have dissipated.
Posamezne študije je treba nadaljevati do spravila ali setve ali sejanja naslednjih kultur, razen če razpade več kot 90 % nanesene količine snovi.
Soil accumulation studies
Študije o kopičenju v tleh
The tests shall provide sufficient data to evaluate the possibility of accumulation of residues of the active substance and of relevant metabolites, degradation and reaction products.
Testi zagotovijo dovolj podatkov za oceno možnosti kopičenja ostankov aktivne snovi, relevantnih metabolitov ter razgradnih in reakcijskih produktov.
Where on the basis of soil dissipation studies it is established that DT90f > 1 year and where repeated application is envisaged, whether in the same growing season or in succeeding years, the possibility of accumulation of residues in soil and the level at which a plateau concentration is achieved must be investigated except where reliable information can be provided by a model calculation or another appropriate assessment.
Kadar se na podlagi študij o razpadu v tleh ugotovi, da je DT90f daljši od enega leta in kadar so predvideni večkratni nanosi v isti rastni dobi ali naslednjih letih, je treba preučiti možnost kopičenja ostankov v tleh in vrednost, pri kateri je dosežena najvišja koncentracija, razen kadar je mogoče iz modela izračuna ali druge primerne ocene pridobiti zanesljive informacije.
Long-term field studies must be done on two relevant soils and involve multiple applications.
Dolgoročne terenske študije je treba izvesti na dveh relevantnih vrstah tal in s ponavljajočimi nanosi.
Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed.
Pred začetkom izvajanja teh študij vlagatelj zahteva od pristojnih organov soglasje za vrsto študije, ki se bo izvajala.
Adsorption and desorption
Adsorpcija in desorpcija
The data and information provided, together with other relevant data and information, should be sufficient to establish the adsorption coefficient of the active substance and of relevant metabolites, degradation and reaction products.
Predloženi podatki in informacije, skupaj z drugimi relevantnimi podatki in informacijami, morajo zadoščati za določitev koeficienta adsorpcije aktivne snovi, relevantnih metabolitov ter razgradnih in reakcijskih produktov.
The studies 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 trees.
Vedno je treba navesti študije, razen kadar narava ali način uporabe pripravkov, ki vsebujejo aktivno snov, preprečuje onesnaženje tal, kot je uporaba na shranjenih proizvodih ali za zdravljenje poškodb na drevesih.
Studies on the active substance must be reported for four soil types.
Navesti je treba študije o aktivni snovi za štiri vrste tal.
Similar studies, for at least three soil types, must be reported for all relevant metabolites, degradation and reaction products which in soil degradation studies account at any time for more than 10 % of the amount of active substance added.
Podobne študije za najmanj tri vrste tal je treba navesti za vse relevantne metabolite ter razgradne in reakcijske produkte, ki kadar koli med študijo o razgradnji v tleh predstavljajo več kot 10 % količine dodane aktivne snovi.
OECD method 106.
Metoda OECD 106.
Mobility in the soil
Mobilnost v tleh
Column leaching studies
Študije o izpiranju v kolonah
The test shall provide sufficient data to evaluate the mobility and leaching potential of the active substance and if possible of relevant metabolites, degradation and reaction products.
Test zagotovi dovolj podatkov za oceno mobilnosti in možnega izpiranja aktivne snovi in, če je mogoče, relevantnih metabolitov ter razgradnih in reakcijskih produktov.
Studies in four soils must be carried out where in the adsorption and desorption studies provided for under point 7.1.2 it is not possible to obtain reliable adsorption coefficient values.
Študije v štirih vrstah tal je treba izvesti, kadar iz študij o adsorpciji in desorpciji iz točke 7.1.2 ni mogoče pridobiti zanesljivih vrednosti za koeficient adsorpcije.
Aged residue column leaching
Stari ostanki pri izpiranju v kolonah
The test shall provide sufficient data to estimate the mobility and leaching potential of relevant metabolites, degradation and reaction products.
Test zagotovi dovolj podatkov za oceno mobilnosti in možnega izpiranja relevantnih metabolitov ter razgradnih in reakcijskih produktov.
The studies must be performed except:
Študije so obvezne, razen kadar:
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, or
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, ali
where a separate study for the metabolite, degradation or reaction product in accordance with point 7.1.2 or point 7.1.3.1 was performed.
je bila izvedena ločena študija za metabolit, razgradni ali reakcijski produkt v skladu s točko 7.1.2 ali 7.1.3.1.
The period(s) of ageing shall be determined from inspection of the degradation patterns of active substance and metabolites to ensure that a relevant spectrum of metabolites is present at the time of leaching.
Dobe staranja se določijo iz pregleda vzorcev razgradnje aktivne snovi in metabolitov, da se zagotovi prisotnost relevantnega spektra metabolitov pri izpiranju.
Lysimeter studies or field leaching studies
Študije z lizimetrom ali terenske študije o izpiranju
The test shall provide data on:
Test zagotovi podatke o:
the mobility in soil,
mobilnosti v tleh,
the potential for leaching to ground water,
možnosti izpiranja v podtalnico,
the potential distribution in soil.
možnosti porazdelitve v tleh.
Expert judgement will be necessary to decide whether lysimeter studies or field leaching studies shall be carried out, taking into account the results of degradation and other mobility studies and the predicted environmental concentrations in groundwater (PECGW), calculated in accordance with Section 9 of the Annex to Regulation (EU) No 545/2011.
Pri odločitvi glede študij z lizimetrom ali terenskih študij o izpiranju bo potrebna strokovna ocena, ki bo upoštevala rezultate študij o razgradnji in drugih študij o mobilnosti ter predvidela koncentracije v podtalnici (PECGW), izračunane v skladu z oddelkom 9 Priloge k Uredbi (EU) št. 545/2011.
The type and conditions of the study to be conducted shall be discussed with the competent authorities.
O vrsti in pogojih študije se razpravlja s pristojnimi organi.
Great care is necessary in design of both experimental installations and individual studies, to ensure that results obtained can be used for assessment purposes.
Pri načrtovanju raziskovalnih pogojev in posameznih študij je potrebna izredna previdnost, da se zagotovi, da bodo lahko pridobljeni rezultati uporabljeni za oceno.
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 ob upoštevanju vrste tal, podnebnih razmer, odmerka, pogostosti in obdobja nanašanja.
Water percolating from soil columns must be analysed at suitable intervals, while residues in plant material must be determined at harvest.
Vodo, ki pronica skozi kolone vzorcev tal, je treba analizirati v primernih časovnih razmikih, ostanke v rastlinskem materialu pa je treba določiti ob spravilu.
Residues in the soil profile in at least five layers must be determined on termination of experimental work.
Na koncu poskusnega dela je treba določiti ostanke v profilu tal v najmanj petih plasteh.
Intermediate sampling must be avoided, since removal of plants (except for harvesting in accordance with normal agricultural practice) and soil cross influences the leaching process.
Vmesnemu vzorčenju se je treba izogibati, saj odstranitev rastlin (razen pri spravilu v skladu z običajno kmetijsko prakso) in plasti tal vpliva na postopek izpiranja.
Precipitation, soil and air temperatures have to be recorded at regular intervals (at least on a weekly base).
Padavine ter temperaturo tal in zraka je treba beležiti v rednih časovnih razmikih (vsaj enkrat na teden).
Lysimeter studies
Študije z lizimetrom
The minimal depth of the lysimeters shall be 100 cm; their maximal depth shall be 130 cm.
Najmanjša globina lizimetrov je 100 cm, največja globina pa 130 cm.
The soil monolith must be undisturbed.
Profil tal ne sme biti moten.
Soil temperatures must be similar to those pertaining in the field.
Temperature vzorcev tal morajo biti podobne tistim na terenu.
Where necessary, supplementary irrigation must be provided to ensure optimal plant growth and to ensure that the quantity of infiltration water is similar to that in the regions for which authorisation is sought.
Kadar je potrebno, je treba zagotoviti dodatno namakanje za optimalno rast rastlin in količino vnesene vode, ki je podobna tisti za območja, za katere se zahteva registracija.
When during the study the soil has to be disturbed for agricultural reasons it must not be disturbed deeper than 25 cm.
Globina obdelave tal med potekom študije ne sme presegati 25 cm.
Field leaching studies
Terenske študije o izpiranju
Information on the groundwater table in the experimental fields must be submitted.
Predložiti je treba informacije o podtalnici na poskusnih terenih.
If soil cracking is observed during the study this must be fully described.
Če se med študijo ugotovijo razpoke v tleh, je treba to v celoti opisati.
Great attention shall be given to the number and the location of water collection devices.
Izbiri števila in lokaciji naprav za zbiranje vode je treba posvetiti posebno pozornost.
The placement of these devices in the soil shall not result in preferential flow paths.
Postavitev teh naprav v tleh ne vpliva na preferenčne poti tokov.
Fate and behaviour in water and air
Končno stanje in obnašanje v zraku in vodi
The information and data provided, taken together with that provided for one or more preparations containing the active substance, and other relevant information, shall be sufficient to establish, or permit estimation of:
Navedene informacije in podatki, skupaj z informacijami in podatki za enega ali več pripravkov, ki vsebujejo aktivno snov, ter druge relevantne 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, sediment organisms and air are at risk,
ravni tveganj za onesnaženje vode, organizmov v usedlinah in zraka,
potential for contamination of surface water and groundwater.
možnosti onesnaženja površinskih vod in podtalnice.
Route and rate of degradation in aquatic systems (as far as not covered by point 2.9)
Pot in hitrost razgradnje v vodnih sistemih (kar ni zajeto v točki 2.9)
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,
establish the relative proportions of the components present and their distribution as between water, including suspended particles, and sediment, and
določitev relativnih deležev prisotnih sestavin in njihove porazdelitve med vodo, vključno s suspendiranimi delci, in usedlino ter
permit the residue of concern and to which non-target species are or may be exposed, to be defined.
opredelitev problematičnih ostankov, ki so jim neciljne vrste izpostavljene ali lahko izpostavljene.
Hydrolytic degradation
Hidrolizna razgradnja
The test must always be performed for relevant metabolites, degradation and reaction products which account at any time for more than 10 % of the amount of active substance added unless sufficient information on their degradation is available from the test performed in accordance with point 2.9.1.
Test je treba vedno izvesti za relevantne metabolite, razgradne in reakcijske produkte, kadar predstavljajo več kot 10 % količine dodane aktivne snovi, razen kadar je iz testa, opravljenega v skladu s točko 2.9.1, na voljo dovolj podatkov o njihovi razgradnji.
The same provisions as provided under the corresponding paragraphs of point 2.9.1 apply.
Uporabljajo se iste določbe kot iz ustreznih odstavkov točke 2.9.1.
Photochemical degradation
Fotokemična razgradnja
The test must always be performed for relevant metabolites, degradation and reaction products which account at any time for more than 10 % of the amount of active substance added unless sufficient information on their degradation is available from the test performed in accordance with points 2.9.2 and 2.9.3.
Test je vedno treba izvesti za relevantne metabolite, razgradne in reakcijske produkte, kadar predstavljajo več kot 10 % količine dodane aktivne snovi, razen kadar je iz testa, opravljenega v skladu s točkama 2.9.2 in 2.9.3, na voljo dovolj podatkov o njihovi razgradnji.
The same provisions as provided under the corresponding paragraphs of points 2.9.2 and 2.9.3 apply.
Uporabljajo se iste določbe kot iz ustreznih odstavkov točk 2.9.2 in 2.9.3.
Biological degradation
Biološka razgradnja
‘Ready biodegradability’
„Hitra biološka razgradnja“
The test must always be performed unless it is not required under Part 4 of Annex I to Regulation (EC) No 1272/2008.
Test je vedno treba izvesti, razen kadar se ga ne zahteva v skladu z delom 4 Priloge I k Uredbi (ES) št. 1272/2008.
Method C 4 of Regulation (EC) No 440/2008.
Metoda C4 Uredbe (ES) št. 440/2008.
Water/sediment study
Študija o vodi/usedlini
The test must be reported unless it can be justified that contamination of surface water will not occur.
Test je treba navesti, razen kadar je mogoče utemeljiti, da ne bo prišlo do onesnaženja površinskih vod.
Degradation in the saturated zone
Razgradnja v nasičenem območju
Transformation rates in the saturated zone of active substances and of relevant metabolites, degradation and reaction products can provide useful information on the fate of these substances in the groundwater.
Podatki o stopnjah transformacije aktivne snovi, relevantnih metabolitov, razgradnih in reakcijskih produktov v nasičenem območju lahko zagotovijo koristne informacije o končnem stanju teh snovi v podtalnici.
Expert judgement is required to decide whether this information is necessary.
Za odločitev o potrebi po teh informacijah je potrebna strokovna ocena.
Route and rate of degradation in air (as far as not covered by point 2.10)
Pot in hitrost razgradnje v zraku (kar ni zajeto v točki 2.10)
Appropriate guidelines are included in the report prepared by the FOCUS [14] Working Group on Pesticides in Air: ‘PESTICIDES IN AIR: CONSIDERATIONS FOR EXPOSURE ASSESSMENT (2008)’.
V poročilo delovne skupine o pesticidih v zraku FOCUS [14] so vključene ustrezne smernice: „PESTICIDI V ZRAKU: POMISLEKI PRI OCENI IZPOSTAVLJENOSTI (2008)“.
Definition of the residue
Opredelitev ostanka
In the light of the chemical composition of residues occurring in soil, water or air, resulting from use, or proposed use, of a plant protection product containing the active substance a proposal for the definition of the residue must be submitted, taking account of both the levels found and their toxicological and environmental significance.
Glede na kemijsko sestavo ostankov v tleh, vodi ali zraku, ki izhajajo iz uporabe ali predlagane uporabe fitofarmacevtskega sredstva, ki vsebuje aktivno snov, je treba predložiti predlog za opredelitev ostanka ob upoštevanju ugotovljene vrednosti ter njegovega toksikološkega in ekološkega pomena.
Monitoring data
Podatki o spremljanju
Available monitoring data concerning fate and behaviour of the active substance and relevant metabolites, degradation and reaction products must be reported.
Navesti je treba razpoložljive podatke o spremljanju končnega stanja in obnašanja aktivne snovi ter relevantnih metabolitov, razgradnih in reakcijskih produktov.
Ecotoxicological studies
Ekotoksikološke študije
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 impact on non-target species (flora and fauna), likely to be at risk from exposure to the active substance, its metabolites, degradation and reaction products, where they are of environmental significance.
Predložene informacije, skupaj z informacijami za enega ali več pripravkov, ki vsebujejo aktivno snov, morajo zadoščati za oceno vpliva na neciljne vrste (flora in favna), ki so lahko ogrožene zaradi izpostavljenosti aktivni snovi, njenim metabolitom, razgradnim in reakcijskim produktom, kadar so pomembni za okolje.
Impact can result from single, prolonged or repeated exposure and can be reversible or irreversible.
Vpliv je lahko posledica enkratne, dolgotrajne ali večkratne izpostavljenosti in je lahko reverzibilen ali nereverzibilen.
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:
permit an evaluation of short- and long-term risks for non-target species — populations, communities, and processes — as appropriate,
oceno kratkoročnih in dolgoročnih tveganj za neciljne vrste – populacije, skupnosti in procese – kot je primerno,
specify the precautions necessary for the protection of non-target species, and
natančno določitev varnostnih ukrepov za zaščito neciljnih vrst, in
specify the pictograms, signal words and relevant hazard and precautionary statements for the protection of the environment, to be mentioned on packaging (containers).
določitev piktogramov, opozorilnih besed ter relevantnih stavkov o nevarnosti in previdnostnih stavkov za zaščito okolja, ki morajo biti navedeni na embalaži (posodah).
There is a need to report all potentially adverse effects found during routine ecotoxicological investigations and to undertake and report, where required by the competent authorities, such additional studies which may be necessary to investigate the probable mechanisms involved and assess the significance of these effects.
Obvezno je poročati o vseh morebitnih škodljivih učinkih, ugotovljenih med rutinskim ekotoksikološkim preučevanjem, ter izvajati in poročati, kadar to zahtevajo pristojni organi, o takšnih dodatnih študijah, ki so lahko potrebne za preučevanje mehanizmov v teh procesih, ter za ocenitev pomena teh učinkov.
All available biological data and information which is relevant to the assessment of the ecotoxicological profile of the active substance must be reported.
Navesti je treba vse dostopne biološke podatke in informacije, ki so relevantne za oceno ekotoksikoloških lastnosti aktivne snovi.
The information on fate and behaviour in the environment, generated and submitted in accordance with points 7.1 to 7.4, and on residue levels in plants generated and submitted in accordance with Section 6 is central to the assessment of impact on non-target species, in that together with information on the nature of the preparation and its manner of use, it defines the nature and extent of potential exposure.
Informacije o končnem stanju in obnašanju v okolju, pridobljene in predložene v skladu s točkami 7.1 do 7.4, ter o vsebnosti ostankov v rastlinah, pridobljenih in predloženih v skladu z oddelkom 6, so osrednjega pomena za oceno vpliva na neciljne vrste in skupaj z informacijami o naravi pripravka in njegovem načinu uporabe opredeljujejo vrsto in obseg možne izpostavljenosti.
The toxicokinetic and toxicological studies and information submitted in accordance with points 5.1 to 5.8 provide essential information as to toxicity to vertebrate species and the mechanisms involved.
Toksikokinetične in toksikološke študije in informacije, predložene v skladu s točkami 5.1 do 5.8, zagotavljajo bistvene informacije o toksičnosti za vretenčarje in vpletene mehanizme.
Full details of the statistical analysis shall be reported (e. g. all point estimates shall be given with confidence intervals, exact p-values should be given rather than stating significant/non-significant).
Navedejo se vse podrobnosti statistične analize (npr. vse posamezne ocene z intervali zaupanja in točne p-vrednosti namesto navedb statistično značilno ali statistično neznačilno).
Test substance
Testna snov
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 radiolabelled material is used.
Kadar se testira aktivna snov, se uporablja 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.