natgillin/translations-raw huggingface dataset:
All packaging used shall comply with the relevant Union legislation on transportation and safe handling.
Vsa uporabljena embalaža je skladna z ustrezno zakonodajo Unije na področju prevoza in varnega ravnanja.
Procedures for destruction and decontamination shall be developed for both small quantities (user level) and large quantities (warehouse level).
Razvijejo se postopki uničenja in dekontaminacije majhnih količin (pri uporabniku) in velikih količin pripravka (v skladišču).
The procedures shall be consistent with provisions in place relating to the disposal of waste and of toxic waste.
Postopki so skladni z veljavnimi določbami, ki urejajo odlaganje odpadkov in toksičnih odpadkov.
The proposed means of disposal shall be without unacceptable influence on the environment and be the most cost effective and feasible.
Predlagani načini odlaganja nimajo nesprejemljivega vpliva na okolje ter so čim bolj stroškovno učinkoviti in tehnično izvedljivi.
Neutralisation procedures (such as by reaction with other substances to form less toxic compounds) for use in the event of accidental spillages shall be described, where such procedures can be applied.
Opišejo se postopki nevtralizacije v primeru nezgodnega razlitja (npr. z reakcijo z drugimi snovmi za tvorbo manj toksičnih spojin), kadar jih je mogoče uporabiti.
The products produced after neutralisation shall be practically or theoretically evaluated and reported.
Snovi, ki nastanejo po nevtralizaciji, se praktično ali teoretično ocenijo in navedejo.
Chemical active substances as well as plant protection products containing them, contaminated materials, or contaminated packaging shall be disposed of through controlled incineration in a licensed incinerator in accordance with the criteria laid down in Directive 94/67/EC of the Council [7].If controlled incineration is not the preferred method of disposal, full information on the alternative method of safe disposal used shall be provided.
Kemijske aktivne snovi in fitofarmacevtska sredstva, ki te snovi vsebujejo, ter kontaminirane snovi ali kontaminirana embalaža se uničijo z nadzorovanim sežigom v sežigalni napravi, ki ima za to uradno dovoljenje, v skladu z merili iz Direktive Sveta 94/67/ES [7].Če nadzorovani sežig ni najprimernejši način uničenja, se navedejo popolne informacije o drugem načinu varnega uničenja, ki se uporabi.
The provisions of this Section cover analytical methods used for the generation of pre-authorisation data and required for post-authorisation control and monitoring purposes.
V določbah tega oddelka so obravnavane analitske metode, ki se uporabljajo za pridobivanje podatkov pred registracijo ter so potrebne za namene nadzora in spremljanja po registraciji.
analytical standards of the purified active substance and of the plant protection product;
analitski standardi čiste aktivne snovi in fitofarmacevtskega sredstva;
In addition, the standards referred to in points (a) and (c) shall, where possible, be made commercially available and, on request, the distributing company shall be named.
Poleg tega se, kadar je to mogoče, zagotovi razpoložljivost standardov iz točk (a) in (c) na trgu, pri čemer se na zahtevo imenuje distribucijsko podjetje.
active substance and/or variant in the plant protection product;
aktivne snovi in/ali variante v fitofarmacevtskem sredstvu;
relevant impurities identified in the technical material or which may be formed during manufacture of the plant protection product or from degradation of the plant protection product during storage;
relevantnih nečistoč, ki so bile ugotovljene v tehničnem materialu ali ki lahko nastanejo med proizvodnjo fitofarmacevtskega sredstva ali zaradi razgradnje fitofarmacevtskega sredstva med skladiščenjem;
relevant co-formulants or components of co-formulants, where required by the national competent authorities.
relevantnih dodatkov ali sestavin dodatkov, če tako zahtevajo nacionalni pristojni organi.
In the case of a plant protection product containing more than one active substance and/or variant a method capable of determining each, in the presence of the other, shall be provided.
Če fitofarmacevtsko sredstvo vsebuje več kot eno aktivno snov in/ali varianto, se navede metoda, s katero je mogoče določiti vsako od njih v prisotnosti drugih.
If a combined method is not submitted, the technical reasons shall be stated.
Če se skupna metoda ne navede, se navedejo tehnični razlogi.
The applicability of CIPAC methods shall be assessed and reported.
Oceni in navede se uporabnost metod CIPAC.
In case of use of a CIPAC method, further validation data shall not be required, but example chromatograms shall be submitted, where available.
Če se uporabi metoda CIPAC, dodatni podatki o potrditvi niso potrebni, predložijo pa se primeri kromatogramov, kadar so na voljo.
In addition, the extent of interference by other substances present in the plant protection product (such as impurities or co-formulants), shall be determined.
Poleg tega se določi obseg motenj drugih snovi v fitofarmacevtskem sredstvu (na primer nečistoč ali dodatkov).
The calibration range shall extend (by at least 20 %) beyond the highest and lowest nominal content of the analyte in relevant analytical solutions.
Kalibracijsko območje presega (za najmanj 20 %) največjo in najmanjšo nominalno vsebnost analita v ustreznih testnih raztopinah.
A minimum of five replicate sample determinations shall be made, and the mean, the relative standard deviation and the number of determinations shall be reported.
Izvede se najmanj pet ponovitvenih določitev vzorca, pri čemer se navedejo povprečje, relativni standardni odmik in število določitev.
The accuracy of the methods shall be determined on at least two representative samples at levels appropriate to the material specification.
Točnost metod se določi na vsaj dveh reprezentativnih vzorcih pri vrednostih, ki ustrezajo specifikaciji snovi.
The mean and the relative standard deviation of the recoveries shall be reported.
Navedeta se povprečje in relativni standardni odmik izkoristkov.
For relevant impurities and, where necessary, for relevant co-formulants the limit of quantification (LOQ) shall be determined and reported and shall be at a concentration of analyte, which is of toxicological or environmental significance, or at the concentration which is formed during storage of the product, where relevant.
Za relevantne nečistoče in po potrebi za ustrezne dodatke se določi in navede meja določanja (LOQ), in sicer pri koncentraciji analita, ki je toksikološko ali okoljsko pomembna, ali pri koncentraciji, ki nastane med shranjevanjem sredstva, kadar je ustrezno.
Methods shall be submitted, with a full description, for the determination of non-isotope-labelled residues in all areas of the dossier, as set out in detail in the following points:
V celoti se opišejo metode za določanje ostankov, ki niso izotopno označeni, na vseh področjih iz dokumentacije, ki so podrobno določena v naslednjih točkah:
in water, buffer solutions, organic solvents and any additional matrices resulting from the physical and chemical properties tests.
v vodi, pufrskih raztopinah, organskih topilih in vseh dodatnih matriksih iz preskusov fizikalnih in kemijskih lastnosti.
The LOQ shall be determined and reported for each component in the residue definition.
Določi in navede se LOQ vsake sestavine iz opredelitve ostankov.
Analytical methods for the determination of the active substance and relevant impurities in the plant protection product shall be submitted, unless the applicant shows that these methods already submitted in accordance with the requirements set out in point 5.1.1 can be applied.
Navedejo se analitske metode za določitev aktivne snovi in relevantnih nečistoč v fitofarmacevtskem sredstvu, razen če vlagatelj dokaže, da se lahko uporabijo metode, ki so že bile predložene v skladu z zahtevami iz točke 5.1.1.
The provisions set out in point 5.1.1 shall apply.
Uporabljajo se določbe iz točke 5.1.1.
Methods, with a full description, shall be submitted for the determination of residues:
V celoti se opišejo metode za določitev ostankov:
in or on plants, plant products, processed food commodities, food and feed of plant and animal origin,
v ali na rastlinah, rastlinskih proizvodih, predelanih živilskih proizvodih ter živilih in krmi rastlinskega in živalskega izvora,
in body fluids and tissues,
v telesnih tekočinah in tkivih,
in soil,
v tleh,
in water,
v vodi,
in air, unless the applicant shows that exposure of operators, workers, residents or bystanders is negligible.
v zraku, razen če vlagatelj dokaže, da je izpostavljenost izvajalcev tretiranja, delavcev, prebivalcev in drugih navzočih oseb zanemarljiva.
The applicant may deviate from such requirement by showing that the methods submitted in accordance with the requirements set out in point 4.2 of Part A of the Annex to Regulation (EU) No 283/2013 can be applied.
Vlagatelju ni treba izpolniti te zahteve, če dokaže, da se lahko uporabijo metode, predložene v skladu z zahtevami iz točke 4.2 dela A Priloge k Uredbi (EU) št. 283/2013.
The specificity of the methods shall enable all components included in the monitoring residue definition to be determined.
Specifičnost metod omogoča določitev vseh sestavin iz opredelitve ostankov za spremljanje.
For residues in or on food and feed of plant and animal origin and residues in drinking water, the reproducibility of the method shall be determined by means of an independent laboratory validation (ILV) and reported.
V zvezi z ostanki v živilih ter krmi rastlinskega in živalskega izvora ali na njej in ostanki v pitni vodi se reproduktibilnost metode določi in navede na podlagi potrditve neodvisnega laboratorija.
The data supplied shall be sufficient to permit an evaluation of the plant protection product to be made.
Predloženi podatki zadoščajo za oceno fitofarmacevtskega sredstva.
It shall be possible to evaluate the nature and extent of benefits that accrue following use of the plant protection product, in comparison to an untreated control and where they exist in comparison to suitable reference products and damage thresholds, and to define its conditions of use.
Oceniti je mogoče naravo in obseg prednosti zaradi uporabe fitofarmacevtskega sredstva v primerjavi z netretirano kontrolo ter z ustreznimi referenčnimi sredstvi in pragi poškodb, če obstajajo, ter določiti pogoje za uporabo.
The number of trials to be conducted and reported shall reflect factors such as the extent to which the properties of the active substances it contains are known and on the range of conditions that arise, including variability in plant health conditions, climatic differences, the range of agricultural practices, the uniformity of the crops, the mode of application the type of harmful organism and the type of plant protection product.
Število poskusov, ki jih je treba izvesti in navesti, je odvisno od dejavnikov, kot so: do kakšne mere so lastnosti aktivnih snovi v pripravku znane, možni pogoji, ki lahko nastanejo, vključno s spremenljivostjo razmer zdravstvenega varstva rastlin, podnebnimi razlikami, razlikami v kmetijski praksi, enakostjo kultur, načinom nanašanja, vrsto škodljivih organizmov in vrsto fitofarmacevtskega sredstva.
Sufficient data shall be submitted to confirm that patterns of use of the plant protection product are representative of the regions and the range of conditions, likely to be encountered in the regions concerned, for which its use is intended.
Predložiti je treba dovolj podatkov za potrditev, da so vzorci uporabe fitofarmacevtskega sredstva reprezentativni za regije in za vse možne pogoje v zadevnih regijah, kjer naj bi se sredstvo uporabilo.
Where the applicant claims that tests in one or more of the proposed regions of use are unnecessary because conditions are comparable with those in other regions where tests have been carried out, the applicant shall substantiate the claim for comparability with documentary evidence.
Če vlagatelj trdi, da je preskušanje v eni ali več od predlaganih regij uporabe nepotrebno, ker so pogoji primerljivi z drugimi regijami, kjer so bili preskusi izvedeni, primerljivost utemelji z listinskimi dokazi.
In order to assess seasonal differences, if any, sufficient data shall be generated and submitted to confirm the performance of the plant protection product in each agronomically and climatically different region for each particular crop (or commodity)/harmful organism combination.
Za oceno sezonskih razlik, če te obstajajo, se pridobi in predloži dovolj podatkov, da se potrdi delovanje fitofarmacevtskega sredstva v vsaki agronomsko in klimatsko različni regiji za vsako kombinacijo posamezne kulture (ali proizvoda)/škodljivega organizma posebej.
Trials on effectiveness and phytotoxicity, where relevant, usually in at least two growing seasons shall be reported.
Kadar je ustrezno, se navedejo poskusi učinkovitosti ali fitotoksičnosti, običajno v najmanj dveh rastnih sezonah.
If the trials from the first season adequately confirm the validity of claims made on the basis of extrapolation of results from other crops, commodities or situations or from tests with closely similar plant protection products, the applicant shall provide a justification for not carrying out a second season’s work.
Če se s poskusi iz prve sezone primerno potrdi veljavnost trditev na podlagi ekstrapolacije rezultatov v zvezi z drugimi kulturami, proizvodi ali situacijami ali na podlagi preskusov z zelo podobnimi fitofarmacevtskimi sredstvi, vlagatelj predloži utemeljitev za neizvajanje preskusa v drugi sezoni.
Where, because of climatic or plant health conditions or other reasons the data obtained in any particular season are of limited value for the assessment of performance, trials in one or more further seasons shall be conducted and reported.
Če pa so podatki, pridobljeni v kateri koli določeni sezoni, zaradi podnebnih razmer, razmer zdravstvenega varstva rastlin ali drugih razlogov le delno koristni za oceno delovanja, se izvedejo in navedejo poskusi še v eni ali več naslednjih sezonah.
Reports in summary form of preliminary tests, including glasshouse and field studies, used to assess the biological activity or dose range finding of the plant protection product and of the active substances it contains, shall be submitted as relevant when requested by the competent authority.
Na zahtevo pristojnega organa se predložijo poročila v obliki povzetka predhodnih preskusov, vključno s študijami v steklenjakih in na terenu, za oceno biološke aktivnosti ali velikosti odmerka fitofarmacevtskega sredstva in aktivnih snovi, ki jih ta vsebuje.
These reports shall provide additional information for the competent authority in order to justify the recommended dose of the plant protection product and, where the plant protection product contains more than one active substance, the ratio of the active substances.
V teh poročilih so navedene dodatne informacije za pristojni organ, da se utemelji priporočeni odmerek fitofarmacevtskega sredstva in razmerje aktivnih snovi, če fitofarmacevtsko sredstvo vsebuje več kot eno aktivno snov.
The tests shall provide sufficient data to permit an evaluation of the level, duration and consistency of control or protection or other intended effects of the plant protection product in comparison to suitable reference products, where they exist.
S preskusi se zagotovi dovolj podatkov za oceno stopnje, trajanja in doslednosti zatiranja ali varstva ali drugih pričakovanih učinkov fitofarmacevtskega sredstva v primerjavi z ustreznimi referenčnimi sredstvi, če ta obstajajo.
A trial shall, where possible, consist of the following three components:
Kadar je to mogoče, poskus sestavljajo naslednji trije elementi:
test product, reference product and untreated control.
preskusno sredstvo, referenčno sredstvo in netretirana kontrola.
The performance of the plant protection product shall be investigated in relation to suitable reference products, where they exist.
Delovanje fitofarmacevtskega sredstva se preuči glede na ustrezna referenčna sredstva, kadar ta obstajajo.
The working spectrum, time and method of application, mode of action shall be close to those of the tested plant protection product.
Območje delovanja, čas in metoda nanašanja ter način delovanja so podobni kot pri preskušanem fitofarmacevtskem sredstvu.
If this is not possible, reference product and test product shall be applied according to their specified use.
Če to ni mogoče, se referenčno in preskusno sredstvo uporabita glede na svojo določeno uporabo.
Plant protection products shall be tested in circumstances where the target harmful organism has been shown to have been present at a level causing or known to cause adverse effects (yield, quality, operational benefit) on an unprotected crop or area or on plants or plant products which have not been treated or where the harmful organism is present at such a level that an evaluation of the plant protection product can be made.
Fitofarmacevtska sredstva se preskusijo v okoliščinah, v katerih se ciljni škodljivi organizem pojavi v tolikšni meri, da povzroča ali lahko povzroči škodljive učinke (donos, kakovost, dobiček) na nevarovanih kulturah ali območju ali na netretiranih rastlinah ali rastlinskih proizvodih, ali v katerih je škodljivi organizem prisoten v tolikšni meri, da je mogoče izvesti oceno fitofarmacevtskega sredstva.
On plant protection products for control of harmful organisms trials shall be performed which show the level of control of the species of harmful organisms concerned or of species representative of groups for which claims are made.
V zvezi s fitofarmacevtskimi sredstvi za zatiranje škodljivih organizmov se izvedejo poskusi, na podlagi katerih se ugotovi stopnja delovanja na zadevne vrste škodljivih organizmov ali vrste, ki spadajo v skupine, za zatiranje katerih je sredstvo namenjeno.
Trials shall include the different stages of growth of life cycle of the harmful species, where this is relevant and the different strains or races, where these are likely to show different degrees of susceptibility.
Poskusi se izvajajo na različnih stopnjah razvoja življenjskega cikla škodljivih organizmov, če je to ustrezno, in na različnih sevih ali rasah, če se predvideva različna stopnja občutljivosti.
Where relevant, these considerations may be addressed in laboratory studies.
Kadar je ustrezno, se lahko ti pomisleki obravnavajo v laboratorijskih študijah.
Trials to provide data on plant protection products which are plant growth regulators, shall show the level of effects on the species to be treated, and include investigation of differences in the response of a representative sample of the range of cultivars on which its use is proposed.
S poskusi za pridobitev podatkov o fitofarmacevtskih sredstvih, ki so regulatorji rasti rastlin, se ugotovi stopnja vpliva na vrste, ki so tretirane, pri čemer ti poskusi vključujejo preučevanje razlik v odzivu reprezentativnega vzorca različnih kultivarjev, za katere je predvidena uporaba sredstva.
In order to clarify the dose response, dose rates lower than the recommended one shall be included in some trials in order to enable assessment of whether the recommended rate is the minimum necessary to achieve the desired effect.
Za pojasnitev učinkovanja odmerka se pri nekaterih poskusih uporabijo nižji odmerki od priporočenih, da se lahko oceni, ali je priporočeni odmerek dejansko najmanjši odmerek, ki je potreben za doseganje želenega učinka.
The duration of the effects of treatment shall be investigated in relation to the control of the target organism or effect on the treated plants or plant products, as appropriate.
Preuči se trajanje učinkov tretiranja v zvezi z zatiranjem ciljnega organizma ali učinka na tretirane rastline ali rastlinske proizvode, če je to primerno.
When more than one application is recommended for the proposed use pattern of the product, trials shall be reported, which establish the duration of the effects of an application, the number of applications necessary and the desired intervals between them.
Kadar se v zvezi s predlaganim načinom uporabe sredstva priporoča več kot en nanos, se navedejo poskusi, s katerimi se določijo trajanje učinkov nanosa, število potrebnih nanosov in potrebni presledki med njimi.
Evidence shall be submitted to show that the dose, timing and method of application recommended give adequate control, protection or have the intended effect in the range of circumstances likely to be encountered in practical use.
Predložijo se dokazi, da priporočeni odmerek, čas nanosa in metoda nanašanja omogočajo ustrezno zatiranje, varstvo ali imajo želeni učinek v vseh okoliščinah, ki lahko nastanejo v praksi.
If there is clear evidence that the performance of the plant protection product is likely to be affected by environmental factors, such as temperature or rain, an investigation of the effects of such factors on performance shall be carried out and reported, particularly where it is known that the performance of chemically related products is so affected.
Če obstajajo jasni dokazi, da okoljski dejavniki, kot je temperatura ali dež, verjetno vplivajo na delovanje fitofarmacevtskega sredstva, se izvede in navede preiskava učinkov takih dejavnikov na delovanje, zlasti če je znano, da vplivajo na delovanje kemijsko sorodnih sredstev.
Where proposed label claims include recommendations for the use of the plant protection product with other plant protection products or adjuvants information on the performance of the mixture shall be provided.
Kadar so na predlagani oznaki proizvoda navedena priporočila za uporabo fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi ali pomožnimi sredstvi, se navedejo informacije o delovanju mešanice.
Trials shall be designed to investigate specified issues, to minimise the effects of random variation between different parts of each site and to enable statistical analysis to be applied to results amenable to such analysis.
Cilji poskusov so preučiti natančno določena vprašanja, čim bolj omejiti učinke naključnih razlik med različnimi deli posamezne lokacije in omogočiti, da se za dobljene rezultate lahko uporabi statistična analiza.
The design, analysis, conduct and reporting of trials shall be in accordance with the specific standards of the European and Mediterranean Plant Protection Organisation (EPPO), where available.
Načrtovanje, analiza in izvedba poskusov ter poročanje o njih so skladni s posebnimi standardi Evropske in sredozemske organizacije za varstvo rastlin (EPPO), če so na voljo.
Deviations from available EPPO guidelines, may be acceptable provided the trials design meets the minimum requirements of the relevant EPPO standard, and is fully described and justified.
Odstopanja od razpoložljivih smernic EPPO so lahko sprejemljiva, če so pri načrtovanju poskusov izpolnjene minimalne zahteve ustreznega standarda EPPO ter je tako načrtovanje v celoti opisano in utemeljeno.
A statistical analysis of results amenable to such analysis shall be carried out;
Izvede se statistična analiza rezultatov, ki se lahko obdelajo s tako analizo;
where necessary the test guideline used shall be adapted to enable such analysis.
po potrebi se uporabljena smernica za preskušanje prilagodi, da se omogoči izvedba take analize.
Where relevant, evidence of yield and quality may be required as a demonstration of effectiveness.
Kadar je ustrezno, se lahko za prikaz učinkovitosti zahtevajo dokazi o donosu in kakovosti.
Laboratory data and where it exists, field information relating to the occurrence and development of resistance or cross-resistance in populations of harmful organisms to the active substances, or to related active substances, shall be provided.
Zagotovijo se laboratorijski podatki in, kadar obstajajo, podatki s terena glede pojava in razvoja odpornosti ali navzkrižne odpornosti populacije škodljivih organizmov na aktivne snovi ali na sorodne aktivne snovi.