natgillin/translations-raw huggingface dataset:
Other methods to dispose of plant protection products, packaging and contaminated materials, where proposed, must be fully described.
Kadar se predlagajo drugi postopki uničenja fitofarmacevtskih sredstev, embalaže in kontaminiranih materialov, jih je treba natančno opisati.
Data must be provided for such methods, to establish their effectiveness and safety.
Za takšne postopke je treba predložiti podatke za določitev njihove učinkovitosti in varnosti.
This Section only covers analytical methods required for post-registration control and monitoring purposes.
Ta oddelek zajema le analitske metode, potrebne za namene nadzora in spremljanja po registraciji.
Descriptions of methods must be provided and include details of equipment, materials and conditions used.
Predložiti je treba opise metod, ki vključujejo podrobnosti o uporabljeni opremi, materialih in pogojih.
As far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment.
Kolikor je to mogoče, je treba za izvajanje teh metod uporabljati najenostavnejši pristop, ki zahteva najnižje stroške in splošno dostopno opremo.
For this Section the following applies:
V tem oddelku velja naslednje:
Impurities, metabolites, relevant metabolites
Nečistoče, metaboliti relevantni, metaboliti
As defined in Article 3 of Regulation (EC) No 1107/2009
kakor je določeno v členu 3 Uredbe (ES) št. 1107/2009
Impurities of toxicological and/or ecotoxicological or environmental concern
nečistoče s toksikološkim in/ali ekotoksikološkim učinkom ali učinkom na okolje
samples of the preparation;
pripravka;
samples of the active substance as manufactured;
aktivne snovi, kot je bila proizvedena;
analytical standards of relevant metabolites and all other components included in the residue definition;
analitskih standardov relevantnih metabolitov in vseh drugih sestavin, ki so opredeljeni kot ostanki;
For definitions see the Annex of Regulation (EU) No 544/2011, points 4.1 and 4.2 of Part A.
Za opredelitve glej točki 4.1 in 4.2 dela A Priloge k Uredbi (EU) št. 544/2011.
Methods for the analysis of the preparation
Metode za analizo pripravka
Methods, which must be described in full, must be provided for the determination of the active substance in the preparation.
Predložiti je treba natančno opisane metode za določitev aktivne snovi v pripravku.
In the case of a preparation containing more than one active substance a method capable of determining each, in the presence of the other, shall be provided.
Kadar pripravek vsebuje več kot eno aktivno snov, se predloži metoda, s katero je mogoče določiti vsako od njih v prisotnosti drugih.
If a combined method is not submitted, the technical reasons must be stated.
Če ni predlagana splošna metoda, je treba navesti tehnične razloge.
The applicability of existing CIPAC methods must be reported.
Poročati je treba o uporabnosti obstoječih metod CIPAC.
Methods must also be provided for the determination in the preparation of relevant impurities, if the composition of the preparation is such that — on the basis of theoretical consideration — such impurities may be formed by its manufacturing process or from degradation during storage.
Predložiti je treba tudi metode za določitev relevantnih nečistoč v pripravku, če je sestava pripravka takšna, da – na podlagi teoretične ocene – v proizvodnem procesu ali zaradi razgradnje med skladiščenjem takšne nečistoče lahko nastanejo.
If required, methods for the determination of co-formulants or constituents of co-formulants in the preparation must be submitted.
Po potrebi je treba predložiti metode za določitev pomožnih snovi v formulaciji ali sestavin pomožnih snovi v formulaciji v pripravku.
Specificity of methods submitted, must be demonstrated and reported.
Določiti in opisati je treba specifičnost predlagane metode.
In addition the extent of interference by other substances present in the preparation must be determined.
Poleg tega je treba določiti obseg motenj drugih snovi, ki so prisotne v pripravku.
While interferences due to other components may be identified as systematic errors in the assessment of the accuracy of methods proposed, an explanation must be provided for any interference occurring which contribute more than ± 3 % to the total quantity determined.
Čeprav se motnje drugih sestavin v oceni točnosti predlagane metode lahko opredelijo kot sistematične napake, je treba predložiti obrazložitev za vse motnje, ki povzročajo več kot ± 3-odstotno odstopanje od celotne določene količine.
The linearity of proposed methods over an appropriate range, must be determined and reported.
Določiti in opisati je treba linearnost predlaganih metod v ustreznem območju.
The calibration range must extend (by at least 20 %) the highest and lowest nominal content of the analyte in relevant analytical solutions of the preparation.
Kalibracijsko območje mora presegati (za najmanj 20 %) najvišjo in najnižjo nominalno vsebnost merjene snovi v ustrezni analitični raztopini pripravka.
Reports submitted must include the equation of the calibration line and the correlation coefficient and representative and properly labelled documentation from the analysis, e.g. chromatograms.
Predložena poročila morajo vključevati izenačitev kalibracijske krivulje in korelacijskega koeficienta ter reprezentančno in ustrezno označeno dokumentacijo analize, na primer kromatograme.
Accuracy will normally only be required for methods for the determination of pure active substance and relevant impurities in the preparation.
Točnost metod se običajno zahteva le za določitev čiste aktivne snovi in relevantnih nečistoč v pripravku.
For the repeatability in principle a minimum of five determinations must be made.
Za ponovljivost je načeloma potrebnih najmanj pet meritev.
An explanation as to the reason for the occurrence of individual outliers, must be attempted.
Razložiti je treba razlog za pojav posameznih največjih odstopanj v katero koli smer.
Analytical methods for the determination of residues must be submitted unless it is justified that the methods already submitted in accordance with the requirements of the Annex to Regulation (EU) No 544/2011, Part A, point 4.2 can be applied.
Analitske metode za določanje ostankov je treba predložiti, razen če se utemelji, da se lahko uporabijo metode, že predložene v skladu z zahtevami iz točke 4.2 dela A Priloge k Uredbi (EU) št. 544/2011.
The same provisions as provided in point 4.2, Part A of the Annex to Regulation (EU) No 544/2011 apply.
Uporabljajo se iste določbe iz točke 4.2 dela A Priloge k Uredbi (EU) št. 544/2011.
The data supplied must be sufficient to permit an evaluation of the plant protection product to be made.
Predloženi podatki morajo zadoščati za oceno fitofarmacevtskega sredstva.
In particular it must be possible to evaluate the nature and extent of benefits that accrue following use of the preparation, where they exist in comparison to suitable reference products and damage thresholds, and to define its conditions of use.
Zlasti morajo omogočati oceno vrste in obsega prednosti zaradi uporabe pripravka, kadar obstajajo v primerjavi z ustreznimi referenčnimi sredstvi in pragi poškodb, ter določiti pogoje za uporabo.
The number of trials to be conducted and reported depends mainly on factors such as the extent to which the properties of the active substance(s) 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 v glavnem 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, z enakostjo kultur, načinom nanašanja, vrsto škodljivih organizmov in vrsto fitofarmacevtskega sredstva.
Sufficient data must be generated and submitted to confirm that patterns determined hold for the regions and the range of conditions, likely to be encountered in the regions concerned, for which its use is to be recommended.
Pridobiti in predložiti je treba dovolj podatkov, da se lahko potrdi, da ugotovljeni vzorci veljajo za regije in za vse možne pogoje v zadevnih regijah, v katerih se priporoča njihova uporaba.
Where an 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 must substantiate the claim for comparability with documentary evidence.
Kadar vlagatelj trdi, da je testiranje v eni ali več od predlaganih regij uporabe nepotrebno, ker so pogoji primerljivi z drugimi regijami, kjer so bili testi izvedeni, mora primerljivost utemeljiti z listinskimi dokazi.
In order to assess seasonal differences, if any, sufficient data must 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, je treba pridobiti in predložiti dovolj podatkov, da se potrdi delovanje fitofarmacevtskega sredstva v vsaki agronomsko in podnebno različni regiji za vsako kombinacijo posamezne kulture (ali proizvoda) in škodljivega organizma.
Normally trials on effectiveness or phytotoxicity, where relevant, in at least two growing seasons must be reported.
Običajno je treba poročati o poskusih učinkovitosti ali fitotoksičnosti, kadar je relevantno, v najmanj dveh rastnih sezonah.
If to the opinion of the applicant 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 preparations, a justification, which is acceptable to the competent authority for not carrying out a second season’s work must be provided.
Če po mnenju vlagatelja poskusi za prvo sezono primerno potrjujejo veljavnost trditev na podlagi ekstrapolacije rezultatov iz drugih kultur, proizvodov ali situacij ali na podlagi testov z zelo podobnimi pripravki, je treba predložiti utemeljitev za neizvajanje testa tudi v drugi sezoni, ki je sprejemljiva za pristojni organ.
Conversely, 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 must be conducted and reported.
Če pa imajo podatki v določeni sezoni omejeno vrednost za oceno delovanja zaradi podnebnih razmer, razmer zdravstvenega varstva rastlin ali drugih razlogov, je treba poskuse izvesti še v eni ali več naslednjih sezonah in jih navesti.
Preliminary tests
Predhodni testi
Reports in summary form of preliminary tests, including glasshouse and field studies, used to assess the biological activity and dose range finding of the plant protection product and of the active substance(s) it contains, must be submitted when requested by the competent authority.
Na zahtevo pristojnega organa je treba predložiti poročila v obliki povzetka o predhodnih testih, vključno s študijami v steklenjakih in na prostem, za oceno biološke aktivnosti in velikosti odmerka fitofarmacevtskega sredstva in aktivnih snovi, ki jih vsebuje.
These reports will provide additional information for the competent authority when it evaluates the plant production product.
Ta poročila bodo zagotovila dodatne informacije za pristojni organ pri oceni fitofarmacevtskega sredstva.
Where this information is not submitted a justification which is acceptable to the competent authority must be provided.
Če se teh podatkov ne predloži, je potrebna utemeljitev, sprejemljiva za pristojni organ.
Testing effectiveness
Testiranje učinkovitosti
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.
Testi zagotovijo 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.
Normally a trial consists of three components: test product, reference product and untreated control.
Običajno poskus sestavljajo trije elementi: testno sredstvo, referenčno sredstvo in netretirana kontrola.
The performance of the plant protection product must be investigated in relation to suitable reference products, where they exist.
Delovanje fitofarmacevtskega sredstva je treba preučevati glede na ustrezna referenčna sredstva, kadar ta obstajajo.
A suitable reference product is defined as an authorised plant protection product which has proved a sufficient performance in practice under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use.
Ustrezno referenčno sredstvo pomeni registrirano fitofarmacevtsko sredstvo, ki je v praksi pokazalo zadovoljivo delovanje v razmerah kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami) na področju predlagane uporabe.
In general, formulation type, effects on the harmful organisms, working spectrum and method of application shall be close to those of the tested plant protection product.
Na splošno so vrsta formulacije, vplivi na škodljive organizme, območje delovanja in metoda nanašanja podobni kot za testirano fitofarmacevtsko sredstvo.
Plant protection products must 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 je treba testirati v okoliščinah, ko 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 ko je škodljivi organizem prisoten v tolikšni meri, da se lahko izdela ocena fitofarmacevtskega sredstva.
Trials to provide data on plant protection products for control of harmful organisms must show the level of control of the species of harmful organisms concerned or of species representative of groups for which claims are made.
Poskusi za pridobitev podatkov o fitofarmacevtskih sredstvih za zatiranje škodljivih organizmov morajo pokazati stopnjo delovanja na zadevne vrste škodljivih organizmov ali predstavnike vrst v skupini, za zatiranje katerih je namenjeno.
Trials must 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.
Poskuse je treba izvajati na različnih stopnjah razvoja življenjskega cikla škodljivih organizmov, kadar je to relevantno, in na različnih sevih ali rasah, če se predvidevajo različne stopnje občutljivosti.
Similarly, trials to provide data on plant protection products which are plant growth regulators, must 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.
Podobno morajo poskusi za pridobitev podatkov o fitofarmacevtskih sredstvih, ki so rastni regulatorji, pokazati stopnjo vpliva na vrste, ki se tretirajo, in vključevati preučevanje razlik v odzivu reprezentativnega vzorca različnih kultivarjev, na katerih se predvideva uporaba sredstva.
In order to clarify the dose response, dose rates lower than the recommended one must be included in some trials in order to enable to assess 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 za oceno, ali je priporočeni odmerek zares najmanjši, ki je potreben za doseganje želenega učinka.
The duration of the effects of treatment must be investigated in relation to the control of the target organism or effect on the treated plants or plant products, as appropriate.
Preučiti je treba trajanje učinkov tretiranja v zvezi z zatiranjem ciljnega organizma ali vplivom na tretirane rastline ali rastlinske proizvode, kakor je primerno.
When more than one application is recommended, trials must 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 priporoča več kot en nanos, je treba navesti poskuse, ki določajo trajanje učinkov nanosa, število potrebnih nanosov in potrebne presledke med njimi.
Evidence must 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.
Predložiti je treba dokaze, da priporočeni odmerek, čas nanosa in metoda nanosa omogočajo ustrezno zatiranje, varstvo ali imajo želeni učinek v vseh okoliščinah, ki lahko nastanejo pri praktični uporabi.
Unless there are clear indications that the performance of the plant protection production is unlikely to be affected to a significant degree by environmental factors, such as temperature or rain, an investigation of the effects of such factors on performance must be carried out and reported, particularly where it is known that the performance of chemically related products is so affected.
Razen če ni jasnih znakov, da dejavniki okolja, kot so temperatura ali dež, ne vplivajo v večji meri na delovanje fitofarmacevtskega sredstva, je treba izvesti in navesti preučitev vpliva takih dejavnikov na delovanje, zlasti če je znano, da vplivajo na delovanje kemično sorodnih sredstev.
Where proposed label claims include recommendations for the use of the plant protection product with other plant protection product(s) or adjuvant(s) information on the performance of the mixture must be provided.
Kadar predlagana oznaka priporoča uporabo fitofarmacevtskega sredstva skupaj z drugimi fitofarmacevtskimi sredstvi ali pomožnimi sredstvi, je treba zagotoviti informacije o delovanju mešanice.
Test guideline
Smernice za izvajanje testa
Trials must 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.
Poskuse je treba načrtovati za preučevanje natančno določenih vprašanj, da so učinki naključnih razlik med različnimi deli vsake lokacije čim manjši in da se za dobljene rezultate lahko uporabi statistična analiza.
The design, analysis and reporting of trials must be in accordance with European and Mediterranean Plant Protection Organisation (EPPO) guidelines 152 and 181.
Načrtovanje, analiza in poročilo o poskusih morajo biti v skladu s 152. in 181. smernicami Evropske in sredozemske organizacije za varstvo rastlin (EPPO).
The report shall include a detailed and critical assessment of the data.
Poročilo vključuje podrobno in kritično oceno podatkov.
The trials must be carried out in accordance with specific EPPO guidelines where available, or with guidelines satisfying at least the requirements of the corresponding EPPO guideline.
Poskuse je treba izvajati v skladu s posebnimi smernicami EPPO, kadar so na voljo, ali s smernicami, ki izpolnjujejo vsaj zahteve iz ustreznih smernic EPPO.
A statistical analysis of results amenable to such analysis must be carried out; where necessary the test guideline used must be adapted to enable such analysis.
Izvesti je treba statistično analizo rezultatov, ki se lahko obdelajo s tako analizo; po potrebi je treba spremeniti smernice za testiranje, da se omogoči taka analiza.
Information on the occurrence or possible occurrence of the development of resistance
Informacije o pojavu ali možnem pojavu odpornosti
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 substance(s), or to related active substances, must be provided.
Zagotoviti je treba laboratorijske podatke in, kadar obstajajo, podatke s terena glede pojava in razvoja odpornosti ali križne odpornosti populacije škodljivih organizmov na aktivne snovi ali na sorodne aktivne snovi.
Where such information is not directly relevant to the uses for which authorisation is sought or to be renewed (different species of harmful organism or different crops), it must, if available, nevertheless be provided, as it may provide an indication of the likelihood of resistance developing in the target population.
Kadar se taki podatki ne nanašajo neposredno na vrste uporabe, za katere se zahteva registracija ali podaljšanje registracije (različne vrste škodljivih organizmov ali različne kulture), jih je treba kljub temu zagotoviti, če so na voljo, ker se lahko iz njih ugotovi verjetnost razvoja odpornosti pri ciljni populaciji.
Where there is evidence or information to suggest that, in commercial use, the development of resistance is likely, evidence must be generated and submitted as to the sensitivity of the population of the harmful organism concerned to the plant protection product.
Kadar obstajajo dokazi ali informacije, ki kažejo verjetnost razvoja odpornosti pri komercialni uporabi, je treba pridobiti in predložiti dokaze glede občutljivosti populacije zadevnih škodljivih organizmov na fitofarmacevtsko sredstvo.
In such cases a management strategy designed to minimise the likelihood of resistance or cross-resistance developing in target species must be provided.
V takih primerih je treba zagotoviti strategijo ravnanja, da je verjetnost razvoja odpornosti ali križne odpornosti pri ciljnih vrstah čim manjša.
Effects on the yield of treated plants or plant products in terms of quantity and/or quality
Vplivi na količino in/ali kakovost pridelka tretiranih rastlin ali rastlinskih proizvodov
Effects on the quality of plants or plant products
Vplivi na kakovost rastlin ali rastlinskih proizvodov
The tests shall provide sufficient data to permit an evaluation of the possible occurrence of taint or odour or other quality aspects of plants or plant products after treatment with the plant protection product.
Testi zagotovijo dovolj podatkov za oceno možnega pojava priokusa ali vonja ali drugih kakovostnih vidikov rastlin ali rastlinskih proizvodov po tretiranju s fitofarmacevtskim sredstvom.
The possibility of the occurrence of taint or odour in food crops must be investigated and be reported where:
Raziskati in navesti je treba verjetnost pojava priokusa ali vonja pri kulturah za živila, kadar:
the nature of the products or its use is such that a risk of occurrence of taint or odour might be expected, or
je oblika sredstva ali njegova uporaba taka, da je mogoče pričakovati nevarnost pojava priokusa ali vonja, ali
other products based on the same or a closely similar active ingredient have been shown to present a risk of occurrence of taint or odour.
se je pokazalo pri drugih sredstvih na podlagi enakih ali zelo podobnih aktivnih snovi, da predstavljajo nevarnost pojava priokusa ali vonja.
The effects of plant protection products on other quality aspects of treated plants or plant products must be investigated and reported where:
Raziskati in navesti je treba vpliv fitofarmacevtskih sredstev na druge kakovostne vidike tretiranih rastlin ali rastlinskih proizvodov, kadar: