natgillin/translations-raw huggingface dataset:
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 čas skladiščenja pri uporabi po spravilu
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 izpostavljanja, kot so ostanki, ki izvirajo iz zdravil ali veterinarskih zdravil.
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.
Povzetek in ocena vseh podatkov iz tega oddelka se pripravita v skladu s smernicami pristojnih organov držav članic o obliki 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 mora vključevati podrobno in kritično oceno navedenih podatkov v luči ustreznih 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.
Where metabolism data have been submitted the toxicological significance of any non-mammalian metabolites must be addressed.
Kadar so bili predloženi podatki o presnovi, je treba obravnavati toksikološki pomen vseh produktov presnove 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 if metabolism data have been submitted.
Predložiti je treba shemo presnove pri rastlinah in živalih s kratko razlago porazdelitve in vključenih kemičnih sprememb, če so bili predloženi podatki o presnovi.
The information provided, taken together with that for the active substance as provided for in the Annex to Regulation (EU) No 544/2011 must be sufficient to permit an assessment of the fate and behaviour of the plant protection product in the environment, and of the non-target species likely to be at risk from exposure to it.
Predložene informacije, skupaj z informacijami o aktivni snovi, predloženimi v skladu s Prilogo k Uredbi (EU) št. 544/2011, morajo zadoščati za oceno končnega stanja in obnašanja fitofarmacevtskega sredstva v okolju ter za opredelitev neciljnih vrst, ki bodo verjetno ogrožene zaradi izpostavljenosti sredstvu.
In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the active substance, should be sufficient to:
Informacije, predložene za fitofarmacevtsko sredstvo, skupaj z drugimi relevantnimi informacijami in informacijami za aktivno snov, morajo zadoščati za:
specify the hazard symbols, the indications of danger, and relevant risk and safety phrases or the pictograms, signal words, relevant hazard and precautionary statements, for the protection of the environment, which are to be included on packaging (containers),
natančno določitev simbolov za nevarnost, znakov za nevarnost, opozorilnih in obvestilnih stavkov ali piktogramov, opozorilnih besed ter izjav o nevarnosti za zaščito okolja, ki morajo biti na embalaži (posodah),
predict the distribution, fate, and behaviour in the environment as well as the time courses involved,
predvidevanje porazdelitve, končnega stanja in obnašanja v okolju ter časovne poteke v teh procesih,
identify non-target species and populations for which hazards arise because of potential exposure, and
opredelitev ogroženih neciljnih vrst in populacij zaradi njihove možne izpostavljenosti ter
identify measures necessary to minimise contamination of the environment and impact on non-target species.
določitev ukrepov, potrebnih za zmanjšanje onesnaževanja okolja in vpliva na neciljne vrste.
Where radio-labelled test material is used, point (iv) of the introduction to Section 7 of Part A of the Annex to Regulation (EU) No 544/2011 applies.
Kadar se uporablja testna snov, označena z radioaktivnimi markerji, se uporablja točka (iv) uvoda v oddelek 7 dela A Priloge k Uredbi (EU) št. 544/2011.
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 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).
Predicted environmental concentrations in soil (PECS), water (PECSW and PECGW) and air (PECA).
Predvidene koncentracije v tleh (PECS), vodi (PECSW in PECGW) in zraku (PECA).
Justified estimates must be made of the expected concentrations of the active substance and relevant metabolites, degradation and reaction products, in soil, groundwater, surface water and air, following use as proposed or already occurring.
Za predvidene koncentracije aktivne snovi in relevantnih metabolitov, razgradnih in reakcijskih produktov v tleh, površinskih vodah in zraku po predlagani uporabi ali že obstoječe morajo biti predložene utemeljene ocene.
In addition a realistic worst-case estimation must be made.
Poleg tega je treba priložiti realistično oceno v najhujšem možnem primeru.
For the purposes of the estimation of such concentrations the following definitions apply:
Pri oceni teh koncentracij se uporabljajo naslednje opredelitve:
Predicted environmental concentration in soil (PECS)
Predvidena koncentracija v tleh (PECS)
The level of residues in the top layer of the soil and to which non-target soil organisms may be exposed (acute and chronic exposure).
Koncentracija ostankov v zgornjem sloju tal, ki so jim lahko izpostavljeni neciljni talni organizmi (akutna in kronična izpostavljenost).
Predicted environmental concentration in surface water (PECSW)
Predvidena koncentracija v površinskih vodah (PECSW)
The level of residues, in surface water to which non-target aquatic organisms may be exposed (acute and chronic exposure).
Koncentracija ostankov v površinskih vodah, ki so jim lahko izpostavljeni neciljni vodni organizmi (akutna in kronična izpostavljenost).
Predicted environmental concentration in groundwater (PECGW)
Predvidena koncentracija v podtalnici (PECGW)
The level of residues in groundwater.
Koncentracija ostankov v podtalnici.
Predicted environmental concentration in air (PECA)
Predvidena koncentracija v zraku (PECA)
The level of residues in air, to which man, animals and other non-target organisms may be exposed (acute and chronic exposure).
Koncentracija ostankov v zraku, ki so jim lahko izpostavljeni ljudje, živali in drugi neciljni organizmi (akutna in kronična izpostavljenost).
For the estimation of these concentrations all relevant information on the plant protection product and on the active substance must be taken into account.
Pri oceni teh koncentracij je treba upoštevati vse relevantne informacije o fitofarmacevtskem sredstvu in aktivni snovi.
A useful approach for these estimations is provided in the EPPO schemes for environmental risk assessment [13].
V shemah EPPO za oceno okoljskega tveganja [13] je naveden uporaben pristop za te ocene.
Where relevant the parameters provided for in this Section shall be used.
Kadar je relevantno, se uporabijo parametri iz tega oddelka.
make a best-possible estimation of all relevant processes involved taking into account realistic parameters and assumptions,
izdelati najboljšo možno oceno vseh relevantnih vpletenih procesov, pri čemer se upoštevajo realistični parametri in predpostavke,
where possible be reliably validated with measurements carried out under circumstances relevant for the use of the model,
po možnosti biti zanesljivo validirani z meritvami, opravljenimi v pogojih, ki ustrezajo uporabi modela,
be relevant to the conditions in the area of use.
ustrezati pogojem v območju uporabe.
The information provided must, where relevant, include that referred to in Section 7 of Part A of the Annex to Regulation (EU) No 544/2011.
Predložene informacije morajo, kadar je to relevantno, vključevati informacije iz oddelka 7 dela A Priloge k Uredbi (EU) št. 544/2011.
Where appropriate, the same provisions relating to the information to be provided on the soil used and on its selection apply as provided for under point 7.1 of Part A of the Annex to Regulation (EU) No 544/2011.
Kadar je primerno, se uporabljajo iste določbe v zvezi z informacijami, ki se predložijo glede uporabljenih tal in njihove izbire, kakor je določeno v točki 7.1 dela A Priloge k Uredbi (EU) št. 544/2011.
Rate of degradation in soil
Stopnja razgradnje v tleh
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 under laboratory conditions.
Študije o razgrajevanju v tleh zagotavljajo najboljšo možno oceno časa 50- oz. 90-odstotne razgraditve aktivne snovi (DT50lab in DT90lab) v laboratorijskih pogojih.
The persistence and behaviour of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance to the requirements of point 7.1.1.2 of Part A of the Annex to Regulation (EU) No 544/2011.
Obstojnost in obnašanje fitofarmacevtskih sredstev v tleh je treba preučiti le, če podatkov ni mogoče ekstrapolirati iz podatkov o aktivni snovi, relevantnih metabolitih in razgradnih in reakcijskih produktih, pridobljenih v skladu z zahtevami iz točke 7.1.1.2 dela A Priloge k Uredbi (EU) št. 544/2011.
This extrapolation is, for example, not possible for slow release formulations.
Ta ekstrapolacija na primer ni možna za formulacije, ki se počasi sproščajo.
The rate of aerobic and/or anaerobic degradation in soil must be reported.
Navesti je treba stopnjo aerobne in/ali anaerobne razgradnje v tleh.
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 če se več kot 90 % aktivne snovi razgradi pred iztekom navedenega obdobja.
SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.
SETAC – Postopki za ocenjevanje končnega stanja pesticidov v naravi in njihove ekotoksičnosti
The soil dissipation studies shall provide best-possible 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 zagotavljajo najboljšo možno oceno časa 50- oz. 90-odstotnega razpada aktivne snovi (DT50lab in DT90lab) v terenskih pogojih.
Where relevant, information on relevant metabolites, degradation and reaction products must be collected.
Kadar je to relevantno, je treba zbrati informacije o relevantnih metabolitih ter razgradnih in reakcijskih produktih.
The dissipation and behaviour of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance to the requirements of point 7.1.1.2 of Part A of the Annex to Regulation (EU) No 544/2011.
Razpad in obnašanje fitofarmacevtskih sredstev v tleh se mora preučiti le, če podatkov ni mogoče ekstrapolirati iz podatkov o aktivni snovi, relevantnih metabolitih ter razgradnih in reakcijskih produktih, pridobljenih v skladu z zahtevami iz točke 7.1.1.2 dela A Priloge k Uredbi (EU) št. 544/2011.
This extrapolation is, for example, not possible for slow-release formulations.
Ta ekstrapolacija na primer ni možna za formulacije, ki se počasi sproščajo.
Test conditions and test guideline
Testni pogoji in smernice za izvajanje testa
The same provisions as provided under the corresponding paragraph of point 7.1.1.2.2 of Part A of the Annex to Regulation (EU) No 544/2011 apply.
Uporabljajo se določbe iz ustreznega odstavka točke 7.1.1.2.2 dela A Priloge k Uredbi (EU) št. 544/2011.
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 zagotovijo ocene koncentracij ostankov v tleh pri spravilu ali setvi ali sajenjem naslednjih kultur.
Soil residue studies must be reported unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of point 7.1.1.2.2 of Part A of the Annex to Regulation (EU) No 544/2011.
Študije o ostankih v tleh je treba navesti le, če podatkov ni mogoče ekstrapolirati iz podatkov o aktivni snovi, relevantnih metabolitih ter razgradnih in reakcijskih produktih, pridobljenih v skladu z zahtevami iz točke 7.1.1.2.2 dela A Priloge k Uredbi (EU) št. 544/2011.
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 aktivnih snovi, relevantnih metabolitov ter razgradnih in reakcijskih produktov.
Soil accumulation studies must be reported unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of point 7.1.1.2.2 of Part A of the Annex to Regulation (EU) No 544/2011.
Študije o kopičenju v tleh je treba navesti le, če podatkov ni mogoče ekstrapolirati iz podatkov o aktivni snovi, relevantnih metabolitih ter razgradnih in reakcijskih produktih, pridobljenih v skladu z zahtevami iz točke 7.1.1.2.2 dela A Priloge k Uredbi (EU) št. 544/2011.
The test shall provide sufficient data to evaluate the mobility and leaching potential of the active substance and relevant metabolites, degradation and reaction products.
Test zagotovi dovolj podatkov za oceno mobilnosti in možnosti izpiranja ostankov aktivnih snovi, relevantnih metabolitov ter razgradnih in reakcijskih produktov.
The mobility of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained in accordance with the requirements of points 7.1.2 and 7.1.3.1 of Part A of the Annex to Regulation (EU) No 544/2011.
Mobilnost fitofarmacevtskih sredstev v tleh je treba preučiti le, če podatkov ni mogoče ekstrapolirati iz podatkov, pridobljenih v skladu z zahtevami iz točk 7.1.2 in 7.1.3.1 dela A Priloge k Uredbi (EU) št. 544/2011.
the mobility of the plant protection product in soil,
mobilnosti fitofarmacevtskega sredstva v tleh,
the potential distribution in soils.
možnosti razširjanja v tleh.
Expert judgement will be necessary to decide whether field leaching studies or lysimeter studies shall be carried out, taking into account the results of degradation and mobility studies and the calculated PECS.
Pri odločitvi glede terenskih študij o izpiranju ali študij z lizimetrom bo potrebna strokovna ocena, ki bo upoštevala rezultate študij o razgradnji in mobilnosti ter izračunane vrednosti PECS.
The type of study to be conducted shall be discussed with the competent authorities.
O vrsti študije se razpravlja s pristojnimi organi.
These studies must be performed unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of point 7.1.3 of Part A of the Annex to Regulation (EU) No 544/2011.
Te študije je treba opraviti le, če podatkov ni mogoče ekstrapolirati iz podatkov o aktivni snovi, relevantnih metabolitih ter razgradnih in reakcijskih produktih, pridobljenih v skladu z zahtevami iz točke 7.1.3 dela A Priloge k Uredbi (EU) št. 544/2011.
The same provisions as provided for under the corresponding paragraph of point 7.1.3.3 of Part A of the Annex to Regulation (EU) No 544/2011 apply.
Uporabljajo se določbe iz ustreznega odstavka točke 7.1.3.3. dela A Priloge k Uredbi (EU) št. 544/2011.
Estimation of expected concentrations in soil
Ocena predvidenih koncentracij v tleh
PECS estimations must relate both to a single application at the highest rate of application for which authorisation is sought, and to the maximum number and highest rates of application for which authorisation is sought, for each relevant soil tested, and are expressed in terms of mg of active substance and of relevant metabolites, degradation and reaction products per kg of soil.
Ocene vrednosti PECS morajo upoštevati enkratni nanos z najvišjim odmerkom, za katerega se zahteva registracija, ter največje število in najvišji odmerki, za katere se zahteva registracija, za vsaka relevantna testirana tla, izrazijo pa se v mg aktivne snovi, relevantnih metabolitov ali razgradnih in reakcijskih produktov na kg tal.
The factors to be considered in making PECS estimations relate to direct and indirect application to soil, drift, run off, and leaching and include processes such as volatilisation, adsorption, hydrolysis, photolysis, aerobic and anaerobic degradation.
Pri pripravi ocen PECS je treba upoštevati neposredni in posredni nanos na tla, zanašanje, odtekanje, izpiranje, izhlapevanje, adsorpcijo, hidrolizo, fotolizo ter aerobno in anaerobno razgradnjo.
For the purposes of PECS calculations, the bulk density of soils can be assumed to be 1,5 g/cm3 dry weight, while the depth of the soil layer is assumed to be 5 cm for applications at the soil surface and 20 cm when incorporation in the soil is involved.
Pri izračunih PECS se lahko nasipna teža tal oceni na 1,5 g/cm3 suhe teže, globina plasti tal na 5 cm za nanose na površini tal in 20 cm pri prehajanju v tla.
Where ground cover is present at time of application, it is to be assumed that 50 % (minimum) of the applied dose reaches the soil surface unless actual experimental data give more specific information.
Kadar so med nanosom tla pokrita, se predvideva, da (najmanj) 50 % nanesenega odmerka doseže površino tal, razen če obstajajo dejanski eksperimentalni podatki.
Initial, short-term and long-term PECS calculations (time weighted averages) must be provided:
Zagotoviti je treba izračun začetne, kratkoročne in dolgoročne PECS (časovno utežena povprečja):
initial: immediately after application,
začetna: takoj po nanosu,
short-term: 24 hours, 2 days and 4 days after last application,
kratkoročna: 24 ur, 2 dni in 4 dni po zadnjem nanosu,
long-term: 7, 28, 50 and 100 days after last application, where relevant.
dolgoročna: 7, 28, 50 in 100 dni po zadnjem nanosu, kadar je relevantno.
Fate and behaviour in water
Končno stanje in obnašanje v vodi
Estimation of concentrations in groundwater
Ocena koncentracij v podtalnici
The groundwater contamination routes have to be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions.
Opredeliti je treba poti onesnaženja podtalnice ob upoštevanju ustreznih razmer kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami).
Suitable estimations (calculations) of predicted environmental concentration in groundwater PECGW, of active substance and relevant metabolites, degradation and reaction products, must be submitted.
Predložiti je treba primerne ocene (izračune) predvidenih koncentracij aktivnih snovi, relevantnih metabolitov ter razgradnih in reakcijskih produktov v podtalnici PECGW.
PEC estimations must relate to the maximum number and highest rates of application, for which authorisation is sought.
Ocene PEC morajo upoštevati največje število in najvišje odmerke nanosa, za katere se zahteva registracija.
Expert judgment is required to decide if additional field tests could provide useful information.
Pri odločitvi, ali bi dodatni testi na prostem zagotovili koristne informacije, je potrebna strokovna ocena.
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 soglasje pristojnih organov za vrsto študije, ki se bo izvajala.
Impact on water treatment procedures
Vpliv na postopke čiščenja vode
In cases where this information is necessary, the information provided should permit to establish or to estimate effectiveness of water treatment procedures (drinking water and sewage treatment), and impact on such procedures.
Kadar so te informacije potrebne, morajo zagotovljene informacije omogočati določitev ali oceno učinkovitosti postopkov čiščenja vode (pitne vode in odpadnih vod) in vpliv na te postopke.
Before performing any studies the applicant shall seek the agreement of the competent authorities on the type of information to be provided.
Pred začetkom izvajanja kakršnih koli študij vlagatelj zahteva soglasje pristojnih organov za vrsto informacije, ki se bo predložila.
Estimation of concentrations in surface water
Ocena koncentracij v površinskih vodah
The surface water contamination routes have to be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions.
Opredeliti je treba poti onesnaženja površinskih voda ob upoštevanju ustreznih razmer kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami).
Suitable estimations (calculations) of predicted environmental concentration in surface water PECSW, of active substance and relevant metabolites, degradation and reaction products, must be submitted.
Predložiti je treba primerne ocene (izračune) predvidenih koncentracij aktivnih snovi, relevantnih metabolitov ter razgradnih in reakcijskih produktov v površinskih vodah PECSW.
PEC estimations must relate to the maximum number and highest rates of application, for which authorisation is sought, and be relevant to lakes, ponds, rivers, canals, streams, irrigation/drainage canals and drains.
Ocene PEC morajo upoštevati največje število in najvišje odmerke nanosa, za katere se zahteva registracija, in vključevati jezera, ribnike, reke, potoke, napajalne/odtočne kanale ter drenažne kanale in jarke.
The factors to be considered in making PECSW estimations relate to direct application to water, drift, run-off, discharge via drains and atmospheric deposition, and include processes such as volatilisation, adsorption, advection, hydrolysis, photolysis, biodegradation, sedimentation and re-suspension.
Pri pripravi ocen PECSW je treba upoštevati neposredni nanos na vodo, zanašanje, odtekanje, odvajanje preko drenažnih kanalov in jarkov, usedanje iz zraka, izhlapevanje, adsorpcijo, advekcijo, hidrolizo, fotolizo, biološko razgradnjo, sedimentacijo in resuspenzijo.
Initial, short-term and long-term PECSW calculations relevant to static and slow moving water bodies (time weighted averages) must be provided:
Zagotoviti je treba izračun začetne, kratkoročne in dolgoročne PECSW (časovno utežena povprečja) za statična ali počasi premikajoča se vodna telesa:
long-term: 7, 14, 21, 28, and 42 days after last application, where relevant.
dolgoročna: 7, 14, 21, 28 in 42 dni po zadnjem nanosu, kadar je relevantno.
Fate and behaviour in air
Končno stanje in obnašanje v zraku
The information provided, taken together with that for the active substance(s), must be sufficient to permit an assessment of the impact on non-target species (flora and fauna), of the plant protection product, when used as proposed.
Predložene informacije, skupaj s podatki za aktivne snovi, morajo zadoščati za oceno vpliva predlagane uporabe fitofarmacevtskega sredstva na neciljne vrste (flora in favna).
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.