natgillin/translations-raw huggingface dataset:
In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the active substance, shall be sufficient to:
Informacije, predložene za fitofarmacevtsko sredstvo, skupaj z drugimi relevantnimi informacijami in informacijami za aktivno snov, zlasti zadoščajo 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, to be mentioned on packaging (containers),
natančno določitev simbolov za nevarnost, znakov za nevarnost, ustreznih opozorilnih in obvestilnih stavkov ali piktogramov, opozorilnih besed ter izjav o nevarnosti za zaščito okolja, ki morajo biti navedeni na embalaži (posodah),
permit an evaluation of the 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, kakor je ustrezno,
permit an evaluation of whether special precautions are necessary for the protection of non-target species.
oceno potrebnih posebnih previdnostnih ukrepov za varstvo neciljnih vrst.
There is a need to report all potentially adverse effects found during routine ecotoxicological investigations and to undertake and report such additional studies which may be necessary to investigate the mechanisms involved and assess the significance of these effects.
Obvezno je navesti vse morebitne škodljive učinke, ugotovljene med rutinskim ekotoksikološkim preučevanjem, in izvajati ter poročati o takšnih dodatnih študijah, ki so lahko potrebne za preučevanje mehanizmov v teh procesih, ter za ocenitev pomena teh učinkov.
In general, much of the data relating to impact on non-target species, required for authorisation of plant protection products, will have been submitted and evaluated for the approval of the active substance.
Večina podatkov v zvezi z vplivom na neciljne vrste, ki se zahtevajo za registracijo fitofarmacevtskih sredstev, se predloži in oceni zaradi odobritve aktivne snovi.
The information on fate and behaviour in the environment, generated and submitted in accordance with points 9.1 to 9.3, and on residue levels in plants generated and submitted in accordance with point 8 is central to the assessment of impact on non-target species, in that it provides information on the nature and extent of potential or actual exposure.
Informacije o končnem stanju in obnašanju v okolju, pridobljene in predložene v skladu s točkami 9.1 do 9.3, ter o vsebnosti ostankov v rastlinah, pridobljene in predložene v skladu s točko 8, so osrednjega pomena za oceno vpliva na neciljne vrste, ker zagotavljajo informacije o vrsti in obsegu možne ali dejanske izpostavljenosti.
The final PEC estimations are to be adapted in accordance with the different groups of organisms taking in particular into consideration the biology of the most sensitive species.
Končne ocene PEC je treba prilagoditi glede na različne skupine organizmov ob upoštevanju zlasti biologije najbolj občutljivih vrst.
The toxicological studies and information submitted in accordance with point 7.1 provide essential information as to toxicity to vertebrate species.
Toksikološke študije in informacije, predložene v skladu s točko 7.1, zagotavljajo bistvene informacije o toksičnosti za vretenčarje.
Whenever a study implies the use of different doses, the relationship between dose and adverse effect must be reported.
Kadar koli študija zajema uporabo različnih odmerkov, je treba poročati o razmerju med odmerkom in škodljivim učinkom.
Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with Section 9 of this Annex shall be used.
Kadar so podatki o izpostavljenosti potrebni za odločitev o tem, ali je treba opraviti študijo, se uporabijo podatki, pridobljeni v skladu z oddelkom 9 te priloge.
For the estimation of exposure of organisms all relevant information on the plant protection product and on the active substance must be taken into account.
Pri oceni izpostavljenosti organizmov je treba upoštevati vse relevantne informacije o fitofarmacevtskem sredstvu in aktivni snovi.
A useful approach for these estimations is provided in the EPPO/Council of Europe schemes for environmental risk assessment [15].
V shemah EPPO/Sveta Evrope za oceno okoljskega tveganja [15] je naveden uporaben pristop za te ocene.
Where it appears from available data that the plant protection product is more toxic as the active substance, the toxicity data of the plant protection product have to be used for the calculation of relevant toxicity/exposure ratios.(viii) In the context of the influence that impurities can have on ecotoxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used, as provided for under point 1.4, be provided.
Kadar je iz razpoložljivih podatkov razvidno, da je fitofarmacevtsko sredstvo bolj toksično kot aktivna snov, je za izračun ustreznih razmerij med toksičnostjo in izpostavljenostjo treba uporabiti podatke o toksičnosti fitofarmacevtskega sredstva.(viii) V okviru vpliva, ki ga nečistoče lahko imajo na ekotoksikološko obnašanje, je bistveno, da se za vsako predloženo študijo zagotovi podroben opis (specifikacija) uporabljene snovi, kot je predpisano v točki 1.4.
In order to facilitate the assessment of the significance of test results obtained the same strain of each relevant species shall where possible be used in the various toxicity tests specified.
Za lažjo oceno pomembnosti dobljenih rezultatov se v različnih testih toksičnosti, kadar je to mogoče, uporabi ista podvrsta relevantne vrste.
Possible effects on birds must be investigated except where the possibility that birds will be exposed, directly or indirectly, can be ruled out such as for use in enclosed spaces or wound healing treatments.
Raziskati je treba možen vpliv na ptice, razen kadar je mogoče izključiti možnost posredne ali neposredne izpostavljenosti ptic, kot na primer pri uporabi v zavarovanih prostorih ali pri uporabi premazov za zdravljenje poškodb na drevesih.
The acute toxicity/exposure ratio (TERa), the short-term dietary toxicity/exposure ratio (TERst) and the long-term dietary toxicity/exposure ratio (TERlt) must be reported, where:
Predložiti je treba podatke o razmerju med akutno toksičnostjo in izpostavljenostjo (TERa), razmerju med kratkotrajno oralno toksičnostjo in izpostavljenostjo (TERst) ter razmerju med dolgotrajno oralno toksičnostjo in izpostavljenostjo (TERlt), pri čemer je:
(mg active substance/kg body weight)/ETE (mg active substance/kg body weight)
(mg aktivne snovi/kg telesne teže)/ETE (mg aktivne snovi/kg telesne teže)
(mg active substance/kg food)/ETE (mg active substance/kg food)
(mg aktivne snovi/kg živila)/ETE (mg aktivne snovi/kg živila)
NOEC (mg active substance/kg food)/ETE (mg active substance/kg food)
NOEC (mg aktivne snovi/kg živila)/ETE (mg aktivne snovi/kg živila)
where ETE = estimated theoretical exposure.
ETE je ocenjena teoretična izpostavljenost.
In the case of pellets, granules or treated seeds the amount of active substance in each pellet, granule or seed must be reported as well as the proportion of the LD50 for the active substance in 100 particles and per gram of particles.
Če je fitofarmacevtsko sredstvo v obliki kroglic (pelet), zrnc ali se z njim tretira seme, je treba navesti količino aktivne snovi v vsaki kroglici, zrnu ali semenu ter vrednost LD50 za aktivno snov v 100 delcih in na gram delcev.
The size and shape of pellets or granules must be reported.
Navesti je treba velikost in obliko kroglic ali zrnc.
In the case of baits the concentration of active substance in the bait (mg/kg) must be reported.
Pri vabah je treba navesti koncentracijo aktivne snovi v vabi (mg/kg).
The test shall provide, where possible, LD50 values, the lethal threshold dose, time courses of response and recovery, the NOEL, and must include relevant gross pathological findings.
Test zagotovi, kadar je to mogoče, podatke o vrednosti LD50, letalni dozi, časovnem poteku odziva in okrevanja, NOEL in vseh relevantnih makroskopskih patoloških ugotovitvah.
The acute oral toxicity of preparations must be reported, where TERa or TERst for the active substance(s) in birds are between 10 and 100 or where results from mammal testing give evidence of a significantly higher toxicity of the preparation compared to the active substance unless it can be justified that it is not likely that birds are exposed to the plant protection product itself.
Podatke o akutni oralni toksičnosti pripravkov je treba navesti, kadar je TERa ali TERst za aktivno snov pri pticah med 10 in 100 ter kadar rezultati testiranja na sesalcih kažejo precej višjo toksičnost pripravka v primerjavi z aktivno snovjo, razen če je mogoče utemeljiti, da izpostavljenost ptic fitofarmacevtskemu sredstvu ni verjetna.
The study must be conducted on the most sensitive species identified in the studies provided for in point 8.1.1 or 8.1.2 of Part A of the Annex to Regulation (EU) No 544/2011.
Študijo je treba izvesti na vrstah, ki so bile opredeljene kot najbolj občutljive v študijah, izvedenih v skladu s točko 8.1.1 ali 8.1.2 dela A Priloge k Uredbi (EU) št. 544/2011.
Supervised cage or field trials
Nadzorovani poskusi v kletki ali na prostem
The test will provide sufficient data to evaluate the nature and the extent of the risk in practical conditions of use.
Test zagotovi dovolj podatkov za oceno vrste in obsega tveganja v dejanskih pogojih uporabe.
Where the TERa and TERst are > 100 and when there is no evidence of risk from any further study on the active substance (e.g. reproduction study) no further testing is required.
Kadar sta TERa in TERst > 100 in kadar ni dokazov o tveganju iz nadaljnjih študij o aktivni snovi (npr. študije o razmnoževanju), dodatno testiranje ni obvezno.
In the other cases, expert judgement is necessary to decide whether there is a need to carry out further studies.
V ostalih primerih je potrebna strokovna ocena glede potrebnih dodatnih študij.
This expert judgement will take into account, where relevant, foraging behaviour, repellency, alternative food, actual residue content in the food, persistence of the compound in the vegetation, degradation of the formulated product or treated produce, the amount of predation of the food, acceptance of bait, granules or treated seed and the possibility for bioconcentration.
Ta strokovna ocena bo upoštevala, kadar je to relevantno, obnašanje pri prehranjevanju, odvračanje, iskanje druge vrste živila, dejansko vsebnost ostankov v živilu, obstojnost snovi v vegetaciji, razgradnjo specifične oblike fitofarmacevtskega sredstva ali tretirane rastline, delež hrane živalskega izvora v živilu, vabljivost vab, zrnc ali tretiranih semen ter možnost za biokoncentracijo.
Where TERa and TERst ≤ 10 or TERlt ≤ 5, cage or field trials must be conducted and reported unless a final assessment is possible on the basis of studies in accordance with point 10.1.3.
Kadar sta TERa in TERst ≤ 10 ali je TERlt ≤ 5, je treba izvesti poskuse v kletkah ali na prostem in jih navesti, razen če je končna ocena možna na podlagi študij v skladu s točko 10.1.3.
Acceptance of bait, granules or treated seeds by birds
Vabljivost vab, zrnc ali tretiranih semen za ptice
The test will provide sufficient data to evaluate the possibility of consumption of the plant protection product or plant products treated with it.
Test zagotovi dovolj podatkov za oceno možnosti zaužitja fitofarmacevtskega sredstva ali rastlinskih proizvodov, ki so bili z njim tretirani.
In the case of seed dressings, pellets, baits and preparations which are granules and where TERa ≤ 10, acceptability (palatability) tests must be conducted.
Če gre za obloženo seme, kroglice, vabe in granulirane pripravke in kadar je TERa ≤ 10, je treba opraviti teste vabljivosti (okusnosti).
Effects of secondary poisoning
Učinki sekundarne zastrupitve
Expert judgment is required to decide whether the effects of secondary poisoning shall be investigated.
Za odločitev, ali je treba raziskati učinke sekundarne zastrupitve, je obvezna strokovna ocena.
Possible effects on aquatic species must be investigated except where the possibility that aquatic species will be exposed can be ruled out.
Raziskati je treba možen vpliv na vodne organizme, razen kadar se možnost izpostavljenosti vodnih organizmov lahko izključi.
TERa and TERlt must be reported, where:
TERa in TERlt je treba navesti, pri čemer je:
acute LC50 (mg active substance/l)/realistic worst case PECSW (initial or short-term, in mg active substance/l)
akutni LC50 (mg aktivne snovi/l)/realistično najslabši primer PECSW (začetna ali kratkoročna, v mg aktivne snovi/l)
chronic NOEC (mg active substance/l)/long-term PECSW (mg active substance/l)
kronični NOEC (mg aktivne snovi/l)/dolgoročna PECSW (mg aktivne snovi/l)
Acute toxicity to fish, aquatic invertebrates or effects on algal growth
Akutna toksičnost za ribe, vodne nevretenčarje ali vpliv na rast alg
In principle tests shall be carried out on one species from each of the three groups of aquatic organisms (fish, aquatic invertebrates and algae) as referred to in point 8.2 of Part A of the Annex to Regulation (EU) No 544/2011 in case the plant protection product itself can contaminate water.
Načeloma se test opravi na eni od vrst vsake od treh skupin vodnih organizmov (ribe, vodni nevretenčarji in alge), kot je navedeno v točki 8.2 dela A Priloge k Uredbi (EU) št. 544/2011, kadar fitofarmacevtsko sredstvo lahko onesnaži vodo.
However where the available information permits to conclude that one of these groups is clearly more sensitive, tests on only the most sensitive species of the relevant group have to be performed.
Kadar je iz razpoložljivih informacij razvidno, da je katera od teh skupin vodnih organizmov občutljivejša, je treba teste opraviti samo na najbolj občutljivi vrsti te skupine.
The test must be performed where:
Test je obvezen, kadar:
the acute toxicity of the plant protection product can not be predicted on the basis of the data for the active substance which is especially the case if the formulation contains two or more active substances or co-formulants such as solvents, emulgators, surfactants, dispersants, fertilisers which are able to increase the toxicity in comparison with the active substance, or
na podlagi podatkov za aktivno snov ni mogoče predvideti akutne toksičnosti fitofarmacevtskega sredstva, zlasti v primeru, če formulacija vsebuje dve ali več aktivnih snovi ali pomožnih snovi v formulaciji, kot so topila, emulgatorji, sredstva za zmanjšanje površinske napetosti, dispergenti in mineralna gnojila, ki lahko povečajo toksičnost v primerjavi z aktivno snovjo, ali
the intended use includes direct application on water,
predvidena uporaba vključuje neposredno nanašanje na vodo,
unless suitable studies referred to under point 10.2.4 are available.
razen če so na voljo študije, navedene v točki 10.2.4.
Test conditions and test guidelines
Testni pogoji in smernice za izvajanje testa
The relevant provisions as under the corresponding paragraphs of points 8.2.1, 8.2.4 and 8.2.6 of Part A of the Annex to Regulation (EU) No 544/2011 apply.
Uporabljajo se ustrezne določbe iz ustreznih odstavkov točk 8.2.1, 8.2.4 in 8.2.6 dela A Priloge k Uredbi (EU) št. 544/2011.
Microcosm or mesocosm study
Študija v akvarijih ali bazenih (mikrokozmos ali mezokozmos študija)
The tests must provide sufficient data to evaluate the essential impact on aquatic organisms under field conditions.
Testi morajo zagotoviti dovolj podatkov za oceno osnovnega vpliva na vodne organizme v terenskih pogojih.
Where TERa ≤ 100 or where TERlt ≤ 10, expert judgment must be used to decide whether a microcosm or mesocosm study is appropriate.
Kadar je TERa ≤ 100 ali kadar je TERlt ≤ 10, je treba glede potrebnosti študije v akvarijih ali bazenih (mikrokozmos ali mezokozmos študija) upoštevati strokovno oceno.
This judgment will take into account the results of any additional data over and above those required by the provisions of points 8.2 and 10.2.1 of Part A of the Annex to Regulation (EU) No 544/2011.
Pri oceni se upoštevajo rezultati testov, poleg tistih, ki se zahtevajo v določbah točk 8.2 in 10.2.1 dela A Priloge k Uredbi (EU) št. 544/2011.
Before performing these studies the applicant shall seek the agreement of the competent authorities on the specific aims of the study to be performed and consequently on the type and conditions of the study to be performed.
Pred izvedbo teh študij vlagatelj pridobi soglasje pristojnih organov o posebnih namenih študije ter posledično o vrsti in pogojih potrebne študije.
The study shall include at least the highest likely exposure rate, whether from direct application, drift, drainage or run-off.
Študija vključuje vsaj najvišjo možno stopnjo izpostavljenosti pri neposrednem nanosu, zanašanju, odvodu ali odtekanju fitofarmacevtskega sredstva.
The duration of the study must be sufficient to permit evaluation of all effects.
Trajanje študije mora zadoščati za oceno vseh vplivov.
Appropriate guidelines are included in:
Primerne smernice so navede v:
SETAC — Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991
SETAC – Smernice za testne postopke za pesticide v sladkovodnih bazenih/Delavnica Huntingdon, 3. in 4. julija 1991
Freshwater field tests for hazard assessment of chemicals — European Workshop on Freshwater Field Tests (EWOFFT).
Testi v naravnem sladkovodnem okolju za oceno nevarnosti kemikalij – Evropska delavnica o testih v naravnem sladkovodnem okolju (EWOFFT).
Residue data in fish
Podatki o ostankih v ribah
The test will provide sufficient data to evaluate the potential for occurrence of residues in fish.
Test zagotovi dovolj podatkov za oceno možne prisotnosti ostankov fitofarmacevtskih sredstev v ribah.
In general data are available from bioconcentration studies in fish.
Na splošno so podatki na voljo iz študij o biokoncentraciji v ribah.
Where bioconcentration has been observed in the study performed in accordance with point 8.2.3 of Part A of the Annex to Regulation (EU) No 544/2011, expert judgement is required to decide whether a long-term microcosm or mesocosm study has to be carried out in order to establish the maximum residues likely to be encountered.
Kadar je v študiji, opravljeni v skladu s točko 8.2.3 dela A Priloge k Uredbi (EU) št. 544/2011, opažena biokoncentracija, je potrebna strokovna ocena za odločitev, ali je za določitev najvišjih verjetnih ostankov treba opraviti dolgoročno študijo v akvarijih ali bazenih (mikrokozmos ali mezokozmos študijo).
SETAC — Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991.
SETAC – Smernice za testne postopke za pesticide v sladkovodnih bazenih/Delavnica Huntingdon, 3. in 4. julija 1991.
The studies referred to in points 8.2.2 and 8.2.5 of Part A of the Annex to Regulation (EU) No 544/2011 may be required for particular plant protection products where it is not possible to extrapolate from data obtained in the corresponding studies on the active substance.
Študije iz točk 8.2.2 in 8.2.5 dela A Priloge k Uredbi (EU) št. 544/2011 se lahko zahtevajo za posebna fitofarmacevtska sredstva le, če podatkov ni mogoče ekstrapolirati iz podatkov, pridobljenih iz ustreznih študij o aktivni snovi.
Effects on terrestrial vertebrates other than birds
Posledice za kopenske vretenčarje, razen ptic
Possible effects on wild vertebrate species must be investigated except where it can be justified that it is not likely that terrestrial vertebrates other than birds are exposed, directly or indirectly.
Raziskati je treba možne vplive na divje vrste vretenčarjev, razen kadar je mogoče utemeljiti, da posredna ali neposredna izpostavljenost kopenskih vretenčarjev, razen ptic, ni verjetna.
TERa, TERst and TERlt must be reported, where:
TERa, TERst in TERlt je treba navesti, pri čemer je:
subchronic NOEL (mg active substance/kg food)/ETE (mg active substance/kg food)
subkronični NOEL (mg aktivne snovi/kg živila)/ETE (mg aktivne snovi/kg živila)
chronic NOEL (mg active substance/kg food)/ETE (mg active substance/kg food)
kronični NOEL (mg aktivne snovi/kg živila)/ETE (mg aktivne snovi/kg živila)
In principle the evaluation sequence for the assessment of risks to such species is similar to that for birds.
Načeloma je način presoje za oceno tveganja za navedene vrste podoben kot za ptice.
In practice it is not often necessary to perform further testing as the studies conducted in accordance with the requirements of Section 5 of the Annex to Regulation (EU) No 544/2011 and Section 7 of this Annex would provide the required information.
V praksi dodatni testi pogosto niso potrebni, ker bodo študije, opravljene v skladu z zahtevami iz oddelka 5 Priloge k Uredbi (EU) št. 544/2011 in oddelka 7 te priloge, zagotovile zahtevane informacije.
The test will provide sufficient information to evaluate the nature and the extent of risks for terrestrial vertebrates other than birds in practical conditions of use.
Test zagotovi dovolj informacij za oceno vrste in obsega tveganja za kopenske vretenčarje, razen ptic, v dejanskih pogojih uporabe.
Where TERa and TERst > 100 and where there is no evidence of risk from any further study no further testing is required.
Kadar sta TERa in TERst > 100 in kadar ni dokazov o tveganju iz nadaljnjih študij, dodatno testiranje ni obvezno.
In the other cases, expert judgment is necessary to decide whether there is a need to carry out further studies.
V drugih primerih je potrebna strokovna ocena glede potrebnih dodatnih študij.
This expert judgment will take into account, where relevant, foraging behaviour, repellency, alternative food, actual residue content in the food, persistence of the compound in the vegetation, degradation of the formulated product or treated produce, the amount of predation of the food, acceptance of bait, granules or treated seed and the possibility for bioconcentration.
Strokovna ocena bo upoštevala, kadar je to relevantno, obnašanje pri prehranjevanju, odvračanje in iskanje druge vrste živila, dejansko vsebnost ostankov v živilu, obstojnost sestavine med vegetacijo, razgradnjo formuliranega fitofarmacevtskega sredstva ali tretirane rastline, delež hrane živalskega izvora v živilu, vabljivost vab, zrnc ali tretiranih semen in možnost za biokoncentracijo.
Where TERa and TERst ≤ 10 or TERlt ≤ 5 cage or field trials or other appropriate studies must be reported.
Kadar sta TERa in TERst ≤ 10 ali je TERlt ≤ 5, je treba predložiti rezultate poskusov v kletkah ali na prostem.
Before performing these studies the applicant shall seek the agreement of the competent authorities on the type and conditions of the study to be performed and whether the effects of secondary poisoning shall be investigated.
Pred opravljanjem teh študij vlagatelj pridobi soglasje pristojnih organov o vrsti in pogojih izvajanja študije ter o potrebnosti študije sekundarne zastrupitve.
The possible effects on bees must be investigated except where the product is for exclusive use in situations where bees are not likely to be exposed such as:
Raziskati je treba možen vpliv na čebele, razen kadar je pripravek namenjen izključni uporabi v pogojih, kjer izpostavljenost čebel ni verjetna, kot npr.:
non-systemic preparations for application to soil,
nesistemična sredstva za tretiranje tal,
The hazard quotients for oral and contact exposure (QHO and QHC), must be reported:
Predložiti je treba kvociente tveganja za oralno in kontaktno izpostavljenost (QHO in QHC):
dose/oral LD50 (μg active substance per bee)
odmerek/oralni LD50 (μg aktivne snovi na čebelo)
dose/contact LD50 (μg active substance per bee)
odmerek/kontaktni LD50 (μg aktivne snovi na čebelo)
dose the maximum application rate, for which authorisation is sought, in g of active substance per hectare.
odmerek najvišji odmerek aktivne snovi, za katerega je vložen zahtevek za registracijo, izražen v g aktivne snovi na hektar.
Acute oral and contact toxicity
Akutna oralna in kontaktna toksičnost