natgillin/translations-raw huggingface dataset:
Where the relevant risk quotient analysis indicates a chronic risk to earthworms a field study to determine effects under practical field conditions shall be conducted and reported as an option for refined risk assessment.
Kadar ustrezna analiza količnika tveganja pokaže kronično tveganje za deževnike, se izvede terenska študija za določitev učinkov pod praktičnimi terenskimi pogoji in navede kot možnost za natančnejšo oceno tveganja.
The study design shall reflect the proposed use of the plant protection product, the environmental conditions likely to arise and species that will be exposed.
Pri načrtovanju študije se upoštevajo predlagana uporaba fitofarmacevtskega sredstva, okoljske razmere, do katerih lahko pride, in izpostavljene vrste.
If a study is to be used for risk assessment in relation to metabolites, their concentrations occurring shall be confirmed analytically.
Če bo študija podlaga za oceno tveganja v zvezi z metaboliti, se njihove koncentracije potrdijo z analizo.
Effects on soil organisms (other than earthworms) shall be investigated for all plant protection products, except in situations where soil organisms are not exposed such as:
Učinki na organizme v tleh (razen deževnikov) se preučijo za vsa fitofarmacevtska sredstva, razen v okoliščinah, v katerih organizmi v tleh niso izpostavljeni, kot so:
the toxicity of a plant protection product cannot be reliably predicted to be either the same or lower than the active substance tested in accordance with point 8.4.2 of Part A of the Annex to Regulation (EU) No 283/2013.
ni mogoče zanesljivo predvideti, da je toksičnost fitofarmacevtskega sredstva enaka ali manjša od toksičnosti preskušene aktivne snovi, in sicer v skladu s točko 8.4.2 dela A Priloge k Uredbi (EU) št. 283/2013.
For plant protection products applied as a foliar spray, data on the relevant two non target arthropod species might be taken into account for a preliminary risk assessment.
V zvezi s fitofarmacevtskimi sredstvi, ki se nanašajo s foliarnim škropljenjem ali pršenjem, se lahko pri predhodni oceni tveganja upoštevajo podatki o dveh zadevnih neciljnih vrstah členonožcev.
If effects do occur on either species, testing on Folsomia candida and Hypoaspis aculeifer shall be required (see point 10.4.2.1).
Če so pri kateri koli vrsti ugotovljeni učinki, so potrebni preskusi za vrsti Folsomia candida in Hypoaspis aculeifer (glej točko 10.4.2.1).
If data on Aphidius rhopalosiphi and Typhlodromus pyri are not available then the data outlined in point 10.4.2.1 shall be required.
Če podatki o vrstah Aphidius rhopalosiphi in Typhlodromus pyri niso na voljo, se zahtevajo podatki iz točke 10.4.2.1.
For plant protection products applied as soil treatments directly to soil either as a spray or as a solid formulation, then testing shall be required on both Folsomia candida and Hypoaspis aculeifer (see point 10.4.2.1).
V zvezi s fitofarmacevtskimi sredstvi, ki se nanašajo neposredno na tla kot pripravki za tla v obliki škropiva ali pršila ali kot formulacije v trdni obliki, je treba izvesti preskuse na vrstah Folsomia candida in Hypoaspis aculeifer (glej točko 10.4.2.1).
The test shall provide sufficient information to perform an assessment of the toxicity of the plant protection product to the soil invertebrate indicator species Folsomia candida and Hypoaspis aculeifer.
S preskusom se zagotovi dovolj informacij za izvedbo ocene toksičnosti fitofarmacevtskega sredstva za indikatorski vrsti talnih nevretenčarjev Folsomia candida in Hypoaspis aculeifer.
Testing shall determine a dose-response relationship and the EC10, EC20 and NOEC shall enable the risk assessment to be conducted in accordance with the appropriate risk quotient analysis, taking into account likely exposure, the organic carbon content (foc) of the test medium and the lipophilic properties (Kow) of the active substance in the plant protection product.
S preskusi se določi razmerje med odmerkom in odzivom, na podlagi vrednosti EC10, EC20 in NOEC pa se izvede ocena tveganja v skladu z ustrezno analizo količnika tveganja, pri čemer se upoštevajo verjetna izpostavljenost, vsebnost organskega ogljika (foc) v preskusnem mediju ter lipofilne lastnosti (Kow) aktivne snovi v fitofarmacevtskem sredstvu.
The plant protection product shall be incorporated into the soil to obtain a homogenous soil concentration.
Fitofarmacevtsko sredstvo se vnese v tla, da se pridobi homogena koncentracija v tleh.
The tests shall provide sufficient information to evaluate the risk of the plant protection product for soil organisms (other than earthworms) using a more realistic test substrate or exposure regime.
S preskusi se zagotovi dovolj informacij za oceno tveganja za talne organizme (razen deževnikov) pri uporabi fitofarmacevtskega sredstva z uporabo bolj realističnega preskusnega substrata ali sistema izpostavljenosti.
Further testing shall be required where significant effects are seen following laboratory testing in accordance with the requirements set out in point 8.4.2.1 of Part A of the Annex to Regulation (EU) No 283/2013 or in accordance with point 10.4.2.1 of this Annex and where risk is indicated following the relevant risk quotient analysis.
Dodatno preskušanje je treba izvesti, kadar se opazijo znatni učinki po laboratorijskem preskušanju v skladu z zahtevami iz točke 8.4.2.1 dela A Priloge k Uredbi (EU) št. 283/2013 ali v skladu s točko 10.4.2.1 te priloge in kadar se na podlagi ustrezne analize količnika tveganja ugotovi tveganje.
The need to perform such studies and the type and conditions of the studies to be performed shall be discussed with the national competent authorities.
Potreba po izvedbi takih študij ter vrsta in pogoji študij, ki jih je treba izvesti, se preučijo skupaj z nacionalnimi pristojnimi organi.
Higher-tier tests may take the form of community/population studies (for example. terrestrial model ecosystems, soil mesocosms) or field studies.
Preskusi na višji stopnji se lahko izvedejo v obliki študij skupnosti/populacije (na primer modeli kopenskih ekosistemov, talni mezokozmosi) ali terenskih študij.
changes in community and population structure of both micro and macro-organisms;
Končne točke ključnih učinkov vključujejo:
The test shall provide sufficient data to evaluate the impact of the plant protection products on soil microbial activity in terms of nitrogen transformation.
S preskusom se zagotovi dovolj podatkov za oceno vpliva fitofarmacevtskih sredstev na dejavnost talnih organizmov pri transformaciji dušika.
The effects of plant protection products on soil microbial function shall be investigated if the toxicity of the plant protection product cannot be predicted on the basis of data for the active substance, unless the applicant shows that no exposure occurs.
Preučijo se učinki fitofarmacevtskih sredstev na dejavnost talnih organizmov, če toksičnosti fitofarmacevtskega sredstva ni mogoče napovedati na podlagi podatkov za aktivno snov, razen če vlagatelj dokaže, da izpostavljenost ni možna.
The effects of plant protection products on non-target plants shall be reported, if the toxicity of the plant protection product cannot be predicted on the basis of the data for the active substance, unless the applicant shows that no exposure occurs.
Navedejo se učinki fitofarmacevtskih sredstev na neciljne rastline, če toksičnosti fitofarmacevtskega sredstva ni mogoče napovedati na podlagi podatkov za aktivno snov, razen če vlagatelj dokaže, da izpostavljenost ni možna.
The test shall provide the ER50 values of the plant protection product to non-target plants.
S preskusom se zagotovijo podatki o vrednosti ER50 fitofarmacevtskega sredstva za neciljne rastline.
Studies of effects on non-target plants shall be required for herbicide and plant growth regulator plant protection products and for other plant protection products, where risk cannot be predicted from screening data (see point 10.6.1) or when the risk cannot be reliably predicted on the basis of the active substance data generated in accordance with point 8.6.2 of Part A of the Annex to Regulation (EU) No 283/2013.
Študije učinkov na neciljne rastline je treba izvesti za fitofarmacevtska sredstva, ki delujejo kot herbicid in regulator rasti rastlin, ter za druga fitofarmacevtska sredstva, kadar tveganja ni mogoče predvideti na podlagi podatkov v zvezi s presejalnimi pregledi (glej točko 10.6.1) ali kadar tveganja ni mogoče zanesljivo predvideti na podlagi podatkov o aktivni snovi, pridobljenih v skladu s točko 8.6.2 dela A Priloge k Uredbi (EU) št. 283/2013.
For all granules risk from drift of dust during time of application shall be considered.
V zvezi z vsemi zrnci se upošteva tveganje zaradi zanašanja prahu med nanašanjem.
Where, from the mode of action, it can be clearly established that either seedling emergence or vegetative vigour is only affected, only the relevant study shall be conducted.
Kadar je mogoče na podlagi načina delovanja nedvomno ugotoviti, da je prizadeta kalitev ali rastna moč, se izvede le ustrezna študija.
Dose-response tests on a selection of 6 to 10 monocotyledon and dicotyledon plant species representing as many taxonomic groups as possible shall be required.
Izvedejo se preskusi razmerja med odmerkom in odzivom na izbranih šestih do desetih enokaličnih in dvokaličnih rastlinskih vrstah, ki predstavljajo čim več taksonomskih skupin.
Where on the basis of screening data or other available information, a specific mode of action is evident, or significant differences in species sensitivities are identified, that information shall be used in the selection of the relevant test species.
Kadar je na podlagi podatkov v zvezi s presejalnimi pregledi ali drugih razpoložljivih informacij ugotovljen poseben način delovanja ali znatne razlike v občutljivosti vrst, se te informacije uporabijo pri izbiri ustreznih preskusnih vrst.
If as a result of conducting studies in accordance with points 10.6.1 and 10.6.2 and carrying out a risk assessment, a high risk has been identified, an extended laboratory study on non-target plants addressing lower tier concerns may be required by the national competent authorities.
Če je zaradi izvajanja študij v skladu s točkama 10.6.1 in 10.6.2 ter ocene tveganja opredeljeno visoko tveganje, lahko nacionalni pristojni organi zahtevajo razširjeno laboratorijsko študijo na neciljnih rastlinah, s katero bi se obravnavala vprašanja v zvezi z nižjo stopnjo.
The study shall provide information regarding the potential effects of the plant protection product on non-target plants following a more realistic exposure.
S študijo se zagotovijo informacije v zvezi z možnimi učinki fitofarmacevtskega sredstva na neciljne rastline po bolj realni izpostavljenosti.
Semi-field and field tests to study effects observed on non-target plants following realistic application may be submitted as a basis for a refined risk assessment.
Terenske preskuse in preskuse pod kontroliranimi pogoji na prostem za preučevanje učinkov na neciljne rastline po dejanskem nanosu je mogoče predložiti kot podlago za natančnejšo oceno tveganja.
Testing shall address effects on plant abundance and biomass production at varying distances from the crop or at exposure levels representing varying distances from the crop.
Med preskušanjem se obravnavajo učinki na številčnost rastlin in proizvodnjo biomase na različnih razdaljah od kulture ali na stopnjah izpostavljenosti, ki predstavljajo različno oddaljenost od kulture.
Any available data on the effects of the plant protection product on other terrestrial organisms shall be submitted.
Predložijo se vsi razpoložljivi podatki o učinkih fitofarmacevtskega sredstva na druge kopenske organizme.
Available monitoring data concerning effects of the plant protection product to non-target organisms shall be reported.
Navedejo se razpoložljivi podatki o spremljanju v zvezi z učinki fitofarmacevtskega sredstva na neciljne organizme.
Proposals for the classification and labelling of the plant protection product in accordance with Regulation (EC) No 1272/2008, where applicable, shall be submitted and justified, including:
Predložijo in utemeljijo se predlogi za razvrščanje in označevanje fitofarmacevtskega sredstva v skladu z Uredbo (ES) št. 1272/2008, vključno s:
IDENTITY OF THE PLANT PROTECTION PRODUCT
OPREDELITEV FITOFARMACEVTSKEGA SREDSTVA
Trade name or proposed trade name, and manufacturer's development code number of the preparation if appropriate
Trgovsko ime ali predlagano trgovsko ime in, če je primerno, proizvajalčeva razvojna šifra pripravka
Physical state and nature of the preparation
Agregatno stanje in oblika pripravka
PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT
FIZIKALNE, KEMIJSKE IN TEHNIČNE LASTNOSTI FITOFARMACEVTSKEGA SREDSTVA
Storage stability and shelf-life
Stabilnost med shranjevanjem in rok uporabe
Effects of light, temperature and humidity on technical characteristics of the plant protection product
Učinki svetlobe, temperature in vlage na tehnične značilnosti fitofarmacevtskega sredstva
Explosivity and oxidising properties
Eksplozivnost in oksidacijske lastnosti
Physical, chemical and biological compatibility with other products including plant protection products with which its use is to be authorised
Fizikalna, kemijska in biološka združljivost z drugimi sredstvi, vključno s fitofarmacevtskimi sredstvi, za hkratno uporabo katerih je potrebna registracija
Necessary waiting periods or other precautions to avoid phytopathogenic effects on succeeding crops
Potrebne karence ali drugi varnostni ukrepi za preprečevanje fitopatogenih učinkov na naslednje kulture
FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT
DODATNE INFORMACIJE O FITOFARMACEVTSKEM SREDSTVU
Effects on the yield of treated plants or plant products in terms of quantity and/or quality
Učinki na količino in/ali kakovost donosa tretiranih rastlin ali rastlinskih proizvodov
Effects on the quality of plants or plant products
Učinki na kakovost rastlin ali rastlinskih proizvodov
Observations on undesirable or unintended side-effects, e. g. on beneficial and other non-target organisms, on succeeding crops, other plants or parts of treated plants used for propagating purposes (e. g. seeds, cuttings, runners)
Ugotavljanje neželenih ali nepredvidenih stranskih učinkov, npr. na koristne in druge neciljne organizme, na naslednje kulture, na druge rastline ali dele tretiranih rastlin, namenjene za razmnoževanje (npr. seme, potaknjence, sadike)
Effects on soil micro-organisms
Učinki na talne mikroorganizme
This Part provides data requirements for the authorisation of a plant protection product based on preparations of micro-organisms including viruses.
V tem delu so določeni zahtevani podatki za registracijo fitofarmacevtskega sredstva na podlagi pripravkov iz mikroorganizmov, vključno z virusi.
The term ‘micro-organism’ as defined in the introduction of part B of the Annex to Regulation (EU) No 283/2013, also applies to the Part B of this Annex.
Izraz „mikroorganizem“, kakor je opredeljen v uvodu dela B Priloge k Uredbi (EU) št. 283/2013, se uporablja tudi v delu B te priloge.
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 o statistični analizi (npr. vse ocenjene vrednosti z intervali zaupanja in natančne p-vrednosti namesto navajanja statistično značilno/neznačilno).
Pending the acceptance of specific guidelines at international level, the information required shall be generated using test guidelines accepted by the competent authority (e.g. USEPA guideline [11]);
Do sprejetja posebnih smernic na mednarodni ravni se zahtevane informacije pridobivajo z uporabo razpoložljivih smernic za preskušanje, ki jih sprejme pristojni organ (npr. smernice USEPA [11]);
where appropriate test guidelines as described in Part A of the Annex to Regulation (EU) No 283/2013, shall be adapted in such a way that they are appropriate for micro-organisms.
kadar je primerno, se smernice za preskušanje iz dela A Priloge k Uredbi (EU) št. 283/2013 prilagodijo tako, da so primerne za mikroorganizme.
Where testing is done, a detailed description (specification) of the material used and its impurities, in accordance with the provisions of point 1.4, must be provided.
Kadar se izvede preskus, je treba v skladu s točko 1.4 predložiti natančen opis (specifikacijo) uporabljene snovi in nečistoč, ki jih vsebuje.
In cases where a new preparation is to be dealt with, extrapolation from Part B of the Annex to Regulation (EU) No 283/2013, could be acceptable, provided that all the possible effects of the co-formulants and other components, especially on pathogenicity and infectiveness, are also evaluated.
Pri obravnavanju novega pripravka je lahko sprejemljiva ekstrapolacija iz dela B Priloge k Uredbi (EU) št. 283/2013, če se ocenijo tudi vsi možni učinki dodatkov in drugih sestavin, zlasti na patogenost in kužnost.
The information provided, taken together with that provided for the micro-organism(s), must be sufficient to precisely identify and define preparations.
Predložene informacije, skupaj z informacijami za mikroorganizme, morajo zadoščati za natančno opredelitev pripravkov.
The information and data referred to, unless otherwise specified, are required for all plant protection products.
Navedene informacije in podatki so obvezni za vsa fitofarmacevtska sredstva, razen če je določeno drugače.
This is with the view to identify if any factor could alter the properties of the micro-organism as a plant protection product in comparison to the micro-organism as such, which is treated in Part B of the Annex to Regulation (EU) No 283/2013.
Namen tega je ugotavljanje, ali se lahko zaradi katerega koli dejavnika spremenijo lastnosti mikroorganizma kot fitofarmacevtskega sredstva v primerjavi z mikroorganizmom kot takšnim, obravnavanim v delu B Priloge k Uredbi (EU) št. 283/2013.
The name and address of the applicant must be provided as must the name, position, telephone and fax number of the appropriate person to contact.
Navesti je treba ime in naslov vlagatelja ter ime, položaj, telefonsko številko in številko telefaksa ustrezne osebe za stike.
Where, in addition, the applicant has an office, agent or representative in the Member State in which the authorisation is being sought, the name and address of the local office, agent or representative shall be provided, as shall the name, position, telephone and fax number of the appropriate person to contact.
Kadar ima vlagatelj poleg tega poslovalnico, zastopnika ali predstavnika v državi članici, v kateri želi pripravek registrirati, se navedejo ime in naslov lokalne poslovalnice, zastopnika ali predstavnika ter ime, položaj, telefonska številka in številka telefaksa ustrezne osebe za stike.
The name and address of the manufacturer of the preparation and of each micro-organism in the preparation must be provided as must the name and address of each manufacturing plant in which the preparation and micro-organism are manufactured.
Navesti je treba ime in naslov proizvajalca pripravka in vsakega mikroorganizma v pripravku ter ime in naslov vsakega obrata, v katerem se pripravek in mikroorganizem proizvajata.
A contact point (preferable a central contact point, to include name, telephone and fax numbers) must be provided for each manufacturer.
Za vsakega proizvajalca je treba navesti osebo za stike (po možnosti osrednjo osebo za stike, skupaj z imenom, telefonsko številko in številko telefaksa).
If the micro-organism originates from a producer from which data in accordance with Part B of the Annex to Regulation (EU) No 283/2013 had not been submitted previously, detailed information on the name and species description, as required in point 1.3 of Part B of the Annex to Regulation (EU) No 283/2013 and on impurities, as required in point 1.4 of Part B of the Annex to Regulation (EU) No 283/2013 have to be provided.
Če mikroorganizem izdeluje proizvajalec, ki podatkov v skladu z delom B Priloge k Uredbi (EU) št. 283/2013 ni predložil predhodno, je treba predložiti podrobne informacije v zvezi z imenom in opisom vrste v skladu s točko 1.3 dela B Priloge k Uredbi (EU) št. 283/2013 ter v zvezi z nečistočami v skladu s točko 1.4 dela B Priloge k Uredbi (EU) št. 283/2013 .
Each micro-organism that is subject to the application shall be identified and named at the species level.
Vsak mikroorganizem, za katerega se vloži vloga, se opredeli in poimenuje na ravni vrste.
The micro-organism shall be deposited at a recognised culture collection and given an accession number.
Mikroorganizem se shrani pri priznani zbirki kultur in opremi z referenčno številko.
The scientific name must be stated, as well as the group assignment (bacteria, virus, etc.) and any other denomination relevant to the micro-organism (e.g. strain, serotype).
Navesti je treba znanstveno ime, razvrstitev po skupinah (bakterija, virus itd.) in katero koli drugo poimenovanje, ki ustreza mikroorganizmu (npr. sev, serotip).
These must include the maximum, minimum and nominal content of the viable and non-viable material,
Te navedbe morajo vključevati največjo, najmanjšo in nominalno vsebnost živega in neživega materiala,
the content of co-formulants,
vsebnost dodatkov,
the content of other components (such as by-products, condensates, culture medium, etc.) and contaminating micro-organisms, derived from production process.
vsebnost drugih sestavin (kot so stranski produkti, kondenzati, gojišča kultur itd.) in kontaminantnih mikroorganizmov, ki nastajajo med proizvodnim procesom.
The contents shall be expressed in terms as provided for in Directive 1999/45/EC of the European Parliament and of the Council [12] for chemicals and appropriate terms for micro-organisms (number of active units per volume or weight or any other manner that is relevant to the micro-organism).(iii) Co-formulants must where possible, be identified either by their International Chemical Identification as given in Annex VI to Regulation (EC) No1272/2008, or, if not included in that Regulation, in accordance with both IUPAC and CA nomenclature. Their structure or structural formula must be provided.
Vsebnost se izrazi v enotah iz Direktive 1999/45/ES Evropskega parlamenta in Sveta [12] za kemijske snovi in v primernih enotah za mikroorganizme (število aktivnih enot na volumen ali težo ali kateri koli drug način, ki ustreza mikroorganizmu).(iii) Dodatke je treba, kadar je to mogoče, opredeliti z Mednarodno kemijsko opredelitvijo iz Priloge VI k Uredbi (ES) št. 1272/2008 ali, kadar niso vključene v navedeno uredbo, v skladu z nomenklaturama IUPAC in CA. Navesti je treba njihovo strukturo ali strukturno formulo.
For each component of the co-formulants the relevant EC (EINECS or ELINCS) number and CAS number where they exist, must be provided.
Za vsako sestavino dodatkov je treba navesti ustrezno številko ES (EINECS ali ELINCS) in številko CAS, kadar obstajata.
Where the information provided does not fully identify a co-formulant, an appropriate specification must be provided.
Kadar v predloženih informacijah dodatek ni v celoti opredeljen, je treba predložiti ustrezno specifikacijo.
The trade name of co-formulants, where they exist, must also be provided.
Kadar obstajajo trgovska imena dodatkov, jih je treba tudi predložiti.
For co-formulants the function must be given:
Pri dodatkih je treba navesti njihovo delovanje, in sicer kot:
adhesive (sticker),
adheziv (lepilo),
wetting agent
močilo,
Identification of contaminating micro-organisms and other components derived from production process.
Opredelitev kontaminantnih mikroorganizmov in drugih sestavin, ki nastajajo med proizvodnim procesom
Contaminating micro-organisms must be identified as outlined in point 1.3 of Part B of the Annex to Regulation (EU) No 283/2013.
Kontaminantne mikroorganizme je treba navesti, kakor je opisano v točki 1.3 dela B Priloge k Uredbi (EU) št. 283/2013.
Chemicals (inert components, by-products, etc.) must be identified as outlined in point 1.10 of Part A of the Annex to Regulation (EU) No 283/2013.
Kemijske snovi (inertne sestavine, stranske produkte itd.) je treba navesti, kakor je opisano v točki 1.10 dela A Priloge k Uredbi (EU) št. 283/2013.