natgillin/translations-raw huggingface dataset:
The test shall provide the LD50 values (by oral and contact exposure).
Test zagotovi podatke o vrednosti LD50 (pri oralni in kontaktni izpostavljenosti).
Testing is required if:
Testi so obvezni, če:
the product contains more than one active substance,
fitofarmacevtsko sredstvo vsebuje več kot eno aktivno snov,
the toxicity of a new formulation cannot be reliably predicted to be either the same or lower than a formulation tested in accordance with the provisions of point 8.3.1.1 of Part A of the Annex to Regulation (EU) No 544/2011 or of this point.
ni mogoče zanesljivo predvideti, da je toksičnost nove formulacije enaka ali manjša od toksičnosti formulacije, testirane v skladu z določbami točke 8.3.1.1 dela A Priloge k Uredbi (EU) št. 544/2011 ali te točke.
The test must be carried out in accordance with EPPO Guideline 170.
Test je treba opraviti v skladu s smernicami 170 EPPO.
Residue test
Test ostankov
The test shall provide sufficient information to evaluate possible risks to foraging bees from residual traces of plant protection products remaining on crops.
Test zagotovi dovolj informacij za oceno možnega tveganja za čebele delavke zaradi sledi ostankov fitofarmacevtskih sredstev na kulturah.
Where QHC ≥ 50, expert judgment is required to decide whether the effect of residues must be determined unless there is evidence that there are no significant residual traces remaining on crops which could affect foraging bees or unless sufficient information is available from cage, tunnel or field tests.
Kadar je QHC ≥ 50, je potrebna strokovna ocena za odločitev, ali je treba določiti učinek ostankov, razen v primeru dokazov, da na kulturah ni bistvenih sledi ostankov, ki bi lahko vplivali na čebele delavke, ali zadostnih informacij iz testov v kletki, tunelu ali na prostem.
The median lethal time (LT50) (in hours) following 24-hour exposure to residues on leaves aged during 8 hours must be determined, and reported.
Določiti in navesti je treba podatke o srednjem letalnem času (LT50) (v urah) po 24-urni izpostavljenosti ostankom fitofarmacevtskega sredstva na listih v osmih urah.
Where LT50 is more than 8 hours, no further testing is required.
Kadar je LT50 več kot osem ur, dodatni testi niso potrebni.
Cage tests
Testi v kletki
The test shall provide sufficient information to evaluate possible risks from the plant protection product for bee survival and behaviour.
Test zagotovi dovolj podatkov za oceno možnega tveganja, ki ga fitofarmacevtsko sredstvo predstavlja za preživetje in obnašanje čebel.
Where QHO and QHC are < 50, further testing is not required except if significant effects are observed in the bee brood feeding test or if there are indications for indirect effects such as delayed action or modification of bee behaviour, in those cases cage and/or field tests shall be carried out.
Kadar sta QHO in QHC < 50, dodatni testi niso potrebni, razen če se pri testu hranjenja čebeljega zaroda opazijo pomembni vplivi ali če obstaja sum za posredne učinke, kot npr. zapoznelo delovanje ali sprememba obnašanja čebel, pri čemer se opravi test v kletki in/ali na prostem.
Where QHO and QHC are > 50, cage and/or field testing is required.
Kadar sta QHO in QHC > 50, so testi v kletki in/ali na prostem obvezni.
Where field testing is conducted and reported in accordance with point 10.4.4, it is not necessary to conduct cage tests.
Kadar se v skladu s točko 10.4.4 izvedejo testi na prostem in predložijo njihovi rezultati, testi v kletki niso potrebni.
However, cage tests where conducted, must be reported.
Kadar se testi v kletki izvedejo, je podatke treba obvezno navesti.
The test shall be carried out using healthy bees.
Test se izvede z zdravimi čebelami.
If bees have been treated, e.g. with a varroacide, it is necessary to wait for 4 weeks before using the colony.
Če so bile čebele tretirane, npr. z varoacidom, morajo do uporabe družine za test preteči vsaj štirje tedni.
The tests must be conducted in accordance with EPPO Guideline 170.
Test je treba opraviti v skladu s smernicami 170 EPPO.
Field tests
Testi na prostem
The test shall provide sufficient information to evaluate possible risks from the plant protection product on bee behaviour, colony survival and development.
Test zagotovi dovolj informacij za oceno možnega tveganja, ki ga fitofarmacevtsko sredstvo predstavlja za vedenje čebel ter preživetje in razvoj družine.
Field tests must be conducted where on the basis of expert judgement, taking into account the proposed manner of use and the fate and behaviour of the active substance, significant effects are observed in cage testing.
Teste na prostem je treba opraviti, kadar se na podlagi strokovne ocene ob upoštevanju predlaganega načina uporabe, končnega stanja in obnašanja aktivne snovi, pri testu v kletki opazijo pomembni učinki.
The test shall be carried out using healthy honeybee colonies of similar natural strength.
Test se opravi z zdravimi družinami medonosnih čebel primerljive življenjske moči.
The tests shall be conducted under conditions reasonably representative of the proposed use.
Testi se opravijo v razmerah, ki predstavljajo pogoje predlagane uporabe.
Special effects (larval toxicity, long residual effect, disorienting effects on bees) identified by the field tests may require further investigation using specific methods.
Če se v testih na prostem ugotovijo posebni učinki (toksičnost za ličinke, dolgoročni vplivi ostankov, vpliv na orientacijo čebel), se lahko zahtevajo dodatne preiskave s posebnimi metodami.
Tunnel tests
Testi v tunelu
The test shall provide sufficient information to evaluate the impact on bees resulting from feeding on contaminated honey dew or flowers.
Test zagotovi dovolj informacij za oceno vpliva na čebele zaradi hranjenja na kontaminirani medeni rosi ali cvetovih.
Where it is not possible to investigate certain effects in cage or field trials, a tunnel test shall be carried out, e.g. in the case of plant protection products intended for control of aphids and other sucking insects.
Kadar nekaterih učinkov ni mogoče raziskati s testi v kletki ali na prostem, se opravi test v tunelu, npr. pri fitofarmacevtskih sredstvih, predvidenih za zatiranje listnih uši in drugih sesajočih žuželk.
The effects of plant protection products on non-target terrestrial arthropods (e.g. predators or parasitoids of harmful organisms) must be investigated.
Raziskati je treba vpliv fitofarmacevtskih sredstev na neciljne kopenske členonožce (npr. plenilce ali parazitoide škodljivih organizmov).
The information obtained for these species can also be used to indicate the potential for toxicity to non-target species inhabiting the same environment.
Informacije, pridobljene za te vrste, se lahko uporabijo tudi za določitev možne toksičnosti za neciljne vrste, ki naseljujejo isto okolje.
Laboratory, extended laboratory and semi-field tests
Laboratorijski testi, razširjeni laboratorijski testi in testi pod kontroliranimi pogoji na prostem
The test shall provide sufficient information to evaluate the toxicity of the plant protection product for selected arthropod species that are relevant to the intended use of the product.
Test zagotovi dovolj podatkov za oceno toksičnosti fitofarmacevtskega sredstva za izbrane vrste členonožcev glede na predvideno uporabo fitofarmacevtskega sredstva.
Testing is not required where severe toxicity (> 99 % effect on the organisms compared to control) can be predicted from relevant available data or where the plant protection product is for exclusive use in situations where non-target arthropods are not exposed such as:
Testiranje ni obvezno, kadar je iz relevantnih razpoložljivih podatkov mogoče predvideti hudo toksičnost (> 99-odstotni učinek na organizme v primerjavi s kontrolo) ali kadar se fitofarmacevtsko sredstvo uporablja izključno v pogojih, pri katerih neciljni členonožci niso izpostavljeni, kot so:
Testing is required when significant effects on the organisms in comparison with the control are reported in the laboratory tests at the maximum recommended dose, conducted in accordance with the requirements of point 8.3.2 of Part A of the Annex to Regulation (EU) No 544/2011.
Testiranje je obvezno, kadar se pri laboratorijskih testih, izvedenih v skladu z zahtevami iz točke 8.3.2 dela A Priloge k Uredbi (EU) št. 544/2011, pri največjih priporočenih odmerkih ugotovijo pomembni vplivi na organizme v primerjavi s kontrolo.
Effects on a particular test species are considered to be significant when they exceed the threshold values as defined in the EPPO schemes for the environmental risk assessment unless species-specific threshold values are defined in the respective test guidelines.
Vplivi na določene testne vrste veljajo za pomembne, kadar presežejo mejne vrednosti, kot so opredeljene v shemah EPPO za oceno tveganja za okolje, razen če so v smernicah za testiranje za določeno vrsto postavljene posebne mejne vrednosti.
Testing is also required if:
Testiranje je obvezno tudi, če:
the toxicity of a new formulation cannot be reliably predicted to be either the same or lower than a formulation tested in accordance with the provisions of point 8.3.2 of Part A of the Annex to Regulation (EU) No 544/2011 or of this point,
ni mogoče zanesljivo predvideti, da je toksičnost nove formulacije enaka ali manjša od toksičnosti formulacije, testirane v skladu z določbami točke 8.3.2 dela A Priloge k Uredbi (EU) št. 544/2011 ali te točke,
on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated,
se na podlagi predvidenega načina uporabe ali na podlagi končnega stanja in obnašanja lahko pričakuje stalna ali ponavljajoča se izpostavljenost,
there is a significant change in the proposed use, e.g. from arable crops to orchards, and species relevant to the new use have not previously been tested,
pride do pomembne spremembe v predvideni uporabi, npr. s poljščin na sadovnjake, in vrste, povezane z novo uporabo, predhodno niso bile testirane,
there is an increase in the recommended application rate, above that previously tested under the Annex to Regulation (EU) No 544/2011.
pride do povečanja priporočenega odmerka nad predhodno testiran odmerek v skladu s Prilogo k Uredbi (EU) št. 544/2011.
Where significant effects were observed in the studies performed in accordance with the requirements of point 8.3.2 of Part A of the Annex to Regulation (EU) No 544/2011 or in the case of change of use such as arable crops to orchards, the toxicity of two additional relevant species must be investigated and reported.
Kadar se v študijah, opravljenih v skladu z določbami točke 8.3.2 dela A Priloge k Uredbi (EU) št. 544/2011, ugotovijo pomembni vplivi ali v primeru spremembe uporabe, npr. s poljščin na sadovnjake, je treba preučiti in navesti toksičnost dveh dodatnih relevantnih vrst.
These must be different to the relevant species already tested under point 8.3.2 of Part A of the Annex to Regulation (EU) No 544/2011.
Te vrste se morajo razlikovati od relevantnih vrst, ki so že bile testirane v skladu z določbami točke 8.3.2 dela A Priloge k Uredbi (EU) št. 544/2011.
For a new mixture or formulation, the toxicity shall initially be assessed using the two most sensitive species as identified in studies already performed for which the threshold values were exceeded but effects still remain below 99 %.
Za novo mešanico ali formulacijo se toksičnost najprej oceni za dve najobčutljivejši vrsti, opredeljeni v že opravljenih študijah, za kateri so bile mejne vrednosti presežene, učinek pa še vedno ni presegel 99 %.
This will enable a comparison to be made; if it is significantly more toxic two species relevant to its proposed use must be tested.
Na podlagi rezultatov je mogoče primerjati: če je mešanica ali formulacija precej bolj toksična, je treba testirati dve vrsti, izbrani glede na predvideno uporabo.
Testing must be conducted at a rate equivalent to the maximum rate of application for which authorisation is sought.
Test je treba opraviti z najvišjim odmerkom, za katerega je vložen zahtevek za registracijo.
A sequential testing approach shall be adopted, i.e. laboratory, and if necessary extended laboratory and/or semi-field.
Testiranje je postopno, tj. laboratorijsko, in če je potrebno, razširjeno laboratorijsko in/ali testiranje pod kontroliranimi pogoji na prostem.
Where there will be more than one application per season, the product shall be applied at twice the recommended application rate unless this information is already available from studies performed in accordance with point 8.3.2 of Part A of the Annex to Regulation (EU) No 544/2011.
Kadar se s sredstvom tretira več kot enkrat v sezoni, se uporabi dvakratnik priporočenega odmerka sredstva, razen če niso te informacije že na voljo iz študij, izvedenih v skladu z določbami točke 8.3.2 dela A Priloge k Uredbi (EU) št. 544/2011.
Where on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated (such as the product is to be applied more than three times per season with a re-application of 14 days or less), expert judgment is required to examine whether further testing is required, beyond initial laboratory testing, which will reflect the proposed use pattern.
Kadar se na podlagi predlaganega načina uporabe ali na podlagi končnega stanja in obnašanja lahko pričakuje stalna ali ponavljajoča se izpostavljenost (ko se s sredstvom tretira več kot trikrat v sezoni, s presledki 14 dni ali manj), je za odločitev o tem, ali je potrebno dodatno testiranje, ki presega začetno laboratorijsko testiranje in bo odražalo predvideni način uporabe, obvezna strokovna ocena.
These tests may be performed in the laboratory or under semi-field conditions.
Ti testi se lahko opravijo v laboratoriju ali pod kontroliranimi pogoji na prostem.
When the test is done in the laboratory a realistic substrate such as plant material or a natural soil shall be used.
Če se test opravi v laboratoriju, se uporabi dejanski substrat, kot npr. rastlinski material ali zemlja iz narave.
However it may be more appropriate to carry out field tests.
Vendar je morda primerneje opraviti teste na prostem.
Where relevant testing shall be done in accordance with appropriate guidelines which satisfy at least the requirements for testing as included in SETAC — Guidance document on regulatory testing procedures for pesticides with non-target arthropods.
Kadar je to relevantno, se testiranje opravi v skladu s primernimi smernicami, ki izpolnjujejo vsaj zahteve za testiranje iz smernic SETAC – Smernice za predpisane testne postopke za pesticide pri neciljnih členonožcih.
The tests shall provide sufficient information to evaluate the risk of the plant protection product for arthropods under field conditions.
Testi zagotovijo dovolj informacij za oceno tveganja za členonožce pri uporabi fitofarmacevtskega sredstva v terenskih pogojih.
Where significant effects are seen following laboratory and semi-field exposure, or where on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated expert judgment is required to examine whether more extensive testing is necessary to permit an accurate risk assessment.
Kadar se pri izpostavljenosti v laboratoriju ali pod kontroliranimi pogoji na prostem ugotovijo pomembni učinki ali kadar se na podlagi predlaganega načina uporabe ali na podlagi končnega stanja in obnašanja lahko pričakuje stalna ali ponavljajoča se izpostavljenost, je za odločitev o tem, ali je potrebno obširnejše testiranje, ki bi omogočilo natančno oceno tveganja, obvezna strokovna ocena.
The tests must be conducted under representative agricultural conditions and in accordance with the proposed recommendations for use, resulting in a realistic worst case study.
Teste je treba opraviti v tipičnih razmerah kmetijske pridelave in v skladu s predlaganimi priporočili za uporabo, ki izhajajo iz študije najslabših možnih pogojev uporabe.
A toxic standard shall be included in all tests.
Toksikološki standard se vključi v vse teste.
Effects on earthworms and other soil non-target macro-organisms, believed to be at risk
Vplivi na deževnike in druge potencialno ogrožene neciljne makroorganizme v tleh
The possible impact on earthworms must be reported except where it can be justified that it is not likely that earthworms are exposed, directly or indirectly.
Navesti je treba podatke o možnem vplivu na deževnike, razen kadar je mogoče utemeljiti, da posredna ali neposredna izpostavljenost deževnikov ni verjetna.
TERa and TERlt must be reported where:
TERa in TERlt je treba navesti, pri čemer je:
(mg active substance/kg)/realistic worst case PECS (initial or short-term, in mg active substance/kg)
(mg aktivne snovi/kg)/dejansko najslabši primer PECS (začetna ali kratkoročna, v mg aktivne snovi/kg)
NOEC (mg active substance/kg)/long-term PECS (mg active substance/kg).
NOEC (mg aktivne snovi/kg)/dolgoročna PECS (mg aktivne snovi/kg)
Acute toxicity tests
Testi akutne toksičnosti
The test shall provide the LC50, where possible the highest concentration causing no mortality and the lowest concentration causing 100 % mortality and must include observed morphological and behavioural effects.
Test zagotovi podatke o vrednosti LC50, kadar je mogoče najvišjo koncentracijo, ki še ne povzroča smrtnosti, in najnižjo koncentracijo, ki povzroča 100-odstotno smrtnost, ter podatke o vseh ugotovljenih morfoloških in vedenjskih spremembah deževnikov.
These studies are only required where:
Te študije so obvezne samo, kadar:
the toxicity of a new formulation cannot be reliably predicted from the formulation tested in accordance with the provisions of point 8.4 of Part A of the Annex to Regulation (EU) No 544/2011 or of this point.
ni mogoče zanesljivo predvideti toksičnosti nove formulacije glede na formulacijo, testirano v skladu z določbami točke 8.4 dela A Priloge k Uredbi (EU) št. 544/2011 ali te točke.
The tests must be conducted in accordance to OECD Method 207.
Test je treba opraviti v skladu z metodo 207 OECD.
Tests for sublethal effects
Testi subletalnih vplivov
the toxicity of a new formulation cannot be reliably predicted from the formulation tested in accordance with the provisions of point 8.4 of Part A the Annex to Regulation (EU) No 544/2011 or of this point,
ni mogoče zanesljivo predvideti toksičnosti nove formulacije glede na formulacijo, testirano v skladu z določbami točke 8.4 dela A Priloge k Uredbi (EU) št. 544/2011 ali te točke,
there is an increase in the recommended application rate, above that previously tested.
se priporočeni odmerek poviša nad predhodno testirani odmerek.
The same provisions as under the corresponding paragraphs of point 8.4.2 of Part A of the Annex to Regulation (EU) No 544/2011 apply.
Uporabljajo se iste določbe iz ustreznih odstavkov točke 8.4.2 dela A Priloge k Uredbi (EU) št. 544/2011.
The test shall provide sufficient data to evaluate the effects on earthworms in field conditions.
Test zagotovi dovolj podatkov za oceno vpliva na deževnike v terenskih pogojih.
Where TERlt < 5 a field study to determine effects under practical field conditions must be conducted and reported.
Kadar je TERlt < 5, je treba opraviti terensko študijo za določitev vpliva v terenskih pogojih in navesti njene rezultate.
Expert judgment is required to decide whether residue contents of earthworms shall be investigated.
Za odločitev, ali je treba raziskati vsebnost ostankov v deževnikih, je obvezna strokovna ocena.
Fields selected shall have a reasonable earthworm population.
Izbrana poskusna zemljišča imajo primerno populacijo deževnikov.
The test must be carried out at the maximum proposed application rate.
Test je treba opraviti z najvišjim predlaganim odmerkom fitofarmacevtskega sredstva.
A toxic reference product must be included in the test.
V test je treba vključiti toksikološko referenčno sredstvo.
Effects on other soil non-target macro-organisms
Vpliv na druge neciljne makroorganizme v tleh
The test shall provide sufficient data to evaluate the impact of the plant protection product on macro-organisms that contribute to the breakdown of dead plant and animal organic matter.
Test zagotovi dovolj podatkov za oceno vpliva fitofarmacevtskega sredstva na makroorganizme, ki sodelujejo pri razkroju odmrle rastlinske in živalske organske snovi.
Testing is not required where in accordance with point 9.1 of this Annex, it is evident that DT90 values are less than 100 days, or the nature and manner of use of the plant protection product are such that exposure does not occur or when data from studies on the active substance performed in accordance with the provisions of points 8.3.2, 8.4 and 8.5 of Part A of the Annex to Regulation (EU) No 544/2011, indicate that there is no risk for soil macrofauna, earthworms or soil microflora.
Test ni obvezen, kadar je v skladu točko 9.1 te priloge razvidno, da so vrednosti DT90 nižje od 100 dni ali da sta oblika in način uporabe fitofarmacevtskega sredstva taka, da izpostavljenost ni možna, ali če podatki iz študij o aktivni snovi, opravljenih v skladu s točkami 8.3.2, 8.4 in 8.5 dela A Priloge k Uredbi (EU) št. 544/2011, kažejo, da ni tveganja za makrofavno, deževnike ali mikrofloro v tleh.
Impact on organic matter breakdown must be investigated and reported, where the DT90f values determined in field dissipation studies (point 9.1) are > 365 days.
Vpliv na razkroj organske snovi je treba preučiti in navesti, kadar so vrednosti DT90f, določene v študijah o razpadu fitofarmacevtskega sredstva v naravi (točka 9.1), večje od 365 dni.
The test shall provide sufficient data to evaluate the impact of the plant protection product on soil microbial activity in terms of nitrogen transformation and carbon mineralisation.
Test zagotovi dovolj podatkov za oceno vpliva fitofarmacevtskega sredstva na aktivnost preobrazbe dušika in mineralizacije ogljika talnih mikroorganizmov.
Where the DT90f values determined in field dissipation studies (point 9.1) are > 100 days, impact on soil non-target micro-organisms must be investigated through laboratory testing.
Kadar so vrednosti DT90f, določene v študijah o razpadu fitofarmacevtskega sredstva v naravi (točka 9.1), večje od 100 dni, je treba z laboratorijskim testiranjem raziskati vpliv na neciljne talne mikroorganizme.
Testing is, however, not required if in the studies performed in accordance with the provisions of point 8.5 of Part A of the Annex to Regulation (EU) No 544/2011, deviations from control values in terms of metabolic activity of the microbial biomass after 100 days is < 25 %, and such data are relevant to the uses, nature, and properties of the particular preparation to be authorised.
Testiranje pa ni obvezno, če se na podlagi študij, opravljenih v skladu z določbami točke 8.5 dela A Priloge k Uredbi (EU) št. 544/2011, ugotovi, da so odkloni metabolične aktivnosti mikrobne biomase od kontrolnih vrednosti po 100 dnevih manjši od 25 % in taki podatki ustrezajo uporabam, oblikam in lastnostim fitofarmacevtskega sredstva v postopku registracije.
The test shall provide sufficient data to evaluate the impact of the plant protection product under field conditions on microbial activity.
Test zagotovi dovolj podatkov za oceno vpliva fitofarmacevtskega sredstva na mikrobno dejavnost v terenskih pogojih.
Where at the end of 100 days, measured activity deviates by more than 25 % from the control, in the laboratory testing further testing in the laboratory, under glass and/or in the field may be necessary.
Kadar je po 100 dneh odklon izmerjene aktivnosti glede na kontrolo večji od 25 %, so morda potrebni dodatni testi v laboratoriju, pod steklom ali na prostem.
Available data from biological primary screening in summary form
Povzetek razpoložljivih podatkov predhodnega biološkega pregleda